Dental Device Guide
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Surgical devices · 21 CFR 872 Subpart E

Bone Plate

FDA device type “Plate, Bone”.

FDA codeJEYClass221 CFR872.4760Pathway510(k)ImplantCategoryMaxillofacial plates & screws
Companies listing it
6756 makers
Brands and models
1,462
510(k) clearances
29417 in five years
FDA name
Plate, Bone
1984: 11986: 91987: 11988: 21990: 51991: 11992: 41993: 31994: 91995: 161996: 91997: 111998: 121999: 112000: 122001: 232002: 232003: 132004: 82005: 102006: 32007: 92008: 72009: 42010: 62011: 52012: 102013: 82014: 62015: 72016: 12017: 52018: 72019: 62020: 62021: 42022: 52023: 22024: 52025: 22026: 319801990200020102020

510(k) clearances per year, 1976–2026

Companies that list JEY

67 companies currently list this device type with FDA.

CompanyCountryRoleBrands and models listedClearancesLatest
Dentsply Sirona, Inc.United StatesMaker—1482026
Megagen Implant Co., Ltd.South KoreaMakeri-Gen302026
Osstem Implant Co., Ltd.South KoreaMakerOssbuilder · SMARTbuilder system · SMARTbuilder System(SB1)682026
KLS Martin SE & Co. KGGermanyMaker—432026
StrykerUnited StatesMakeradd name · Burr Hole covers · Custom Mandible Recon Plate · Delta DualStart · +24332024
Materialise NVBelgiumMakerProPlan CMF Guides · SurgiCase CMF Guides · TruMatch CMF Ti 3D-Printed Implants · TruMatch CMF Ti 3D-Printed Plates · +252026
MedCADUnited StatesMakerAccuPlate · AccuPlate 3DTi Patient-Specific Plating System · AccuPlate Patient-Specific Plate42023
Meticuly Co., Ltd.ThailandMakerMETICULY Patient-specific titanium maxillofacial mesh implant22026
Osteomed, LLCUnited StatesMaker—262022
Beijing Naton Technology Group Co. Ltd.ChinaMakerInion CPS 1.5/2/2.5 Bioabsorbable Fixation System · Inion CPS Baby 1.5 Bioabsorbable Fixation System · Inion CPS Baby Biodegradable Fixation System · Inion CPS Biodegradable Fixation System · +3102025
Jeil Medical CorporationSouth KoreaMakerBone Fixation Screw Kit · GBR System · JEIL BONE FIXATION SYSTEM · Leforte MMF System · +2892026
Biomaterials Korea, Inc.South KoreaMakerACR52023
Microware Precision Co., Ltd.TaiwanMakerBiomet Microfixation OmniMax MMF System · LORENZ 1MM, 1.5MM, 2MM SYSTEM · Tandry CMF Plate System22022
Southern Medical (Pty) LtdSouth AfricaMakerSouthern Maxillofacial (MF) system12025
Bioplate, Inc.United StatesMakerBioplate Rigid Fixation Bone · Modified Sterile Plate & Screw kit configurations for use with Bioplate Titanium Fixation System · Plating System · Rigid Fixation Bone Plating System · +6172008
Zimmer IncUnited StatesMakerAND PREBENT · BIOMET MICROFIXATION · Biomet Microfixation OmniMax MMF System · DISTRACTOR SYSTEM · +25142001
Medtronic, Inc.United StatesMakerARCHITEX · MACROPORE FX, PS, NS, LP · MACROPORE PROTECTIVE SHEET · MACROPORE-PX PEDIATRIC SYSTEM · +3112014
Impladent , Ltd.United StatesMakerTriStar Bone Graft Fixation System102014
Unicare Biomedical, Inc.United StatesMakerCYTOFLEX MESH92015
Medicon EGGermanyMaker—92005
Biomet MicrofixationUnited StatesMakerBi Phase · CMF System · Fracture/Reconstruction Plating · Mandibular Fracture/Reconstruction Devices · +1882021
SYNTHES (USA) Products LLCUnited StatesMakerCONDYLAR PROSTHESIS OF MANDIBLE W/HEAD · Depuy Synthes Maxillofacial Portfolio - MR Conditional · ePuy Synthes 2.4mm Ti Self-Tapping MatrixMANDIBLE Screws (26-40mm) · MatrixMANDIBLE Fine Pitch Screws · +3872020
Medartis AGSwitzerlandMakerMODUS 2.5 Mandibular Reconstruction System · MODUS Sagittal Split Plate and Slider · MODUS Titanium Ostheosynthesis System · MODUS TriLock 2/2.3/2.562007
SYNTHES GMBH / Synthes Produktions GmbHUnited StatesMakerMatrixORTHOGNATHIC Plating System · plate · PLATE, BONE · SYNTHES (USA) [SYNTHES] MINI EXTERN · +652013
Osteogenics Biomedical, Inc.United StatesMakerOsteo-Mesh TM-300 Titanium Mesh · RPM Reinforced PTFE Mesh52021
OSTEONIC Co., Ltd.South KoreaMakerOPTIMUS CMF System32021
Surgident Co., Ltd.South KoreaMakerGBR System SD-Screw, Bone Tac · GBR System Titanium Mesh22019
Mci Medical Concept Innovation, Inc.United StatesMakerA011.1000 STRAIGHT MICRO PLATE 4H · A011.1002 STRAIGHT MICRO PLATE 6H · A011.1004 STRAIGHT MICRO PLATE 8H · A011.1006 STRAIGHT MICRO PLATE 10H · +1,06112019
Gebr. Brasseler GmbH & Co. KGGermanyMaker—12007
NEOORTHO Produtos Ortopedicos S/ABrazilMakerCranioMaxillofacial Fixation (CMF) System - CMF Visionare · Mini and Micro Fragments Reconstruction System - NEOFACE · Neoortho · Visionare12010
Dsm BiomedicalUnited StatesMaker—12020
Visionare LLCUnited StatesMakerVISIONARE12018
ReOss GmbHGermanyMakerYxoss12020
Aesculap AGGermanyMaker———
Unique Instruments Inc.United StatesMakerACE Mini Bone Plate System · RESORBABLE FIXATION SYSTEM · SYNTHES CRANIOFACIAL PLATES——
Micro Precision Swiss, LLCUnited StatesMakerTiMesh System for Reconstructive Surgery and Rigid Fixation of the bones of the face and skull · TiMesh Titanium Mini-Softplate/Screw and Micro-Softplate/Screw System · TiMesh Titanium Mini-Softplate/Screw and Micro-Softplate/Screw System for Rigid Fixation of the Bones of the Face and Sk——
LX Precision Shanghai Co. Ltd.ChinaMakerBiomet Microfixation OmniMax MMF System · CMF System · Neuro System · TraumaOne System · +13——
Jabil Inc.United StatesMakerDePuy Synthes 2.4mm Ti Self-Tapping MatrixMANDIBLE Screws (26-40mm) · DePuy Synthes Maxillofacial Portfolio - MR Conditional · Plate · SYNTHES (USA) [SYNTHES] MINI EXTERNAL FIXATOR · +3——
TecometUnited StatesMakerTiMesh Titanium Mini-Softplate/Screw and Micro-Softplate/Screw system——
DePuy Synthes, Inc.United StatesMakerMAXILLARY DISTRACTOR · SYNTHES (USA) [SYNTHES] MINI EXTERN · SYNTHES (USA) RAPID RESORBABLE FIXATION SYSTEM · SYNTHES POLY (L-LACTIDE-CO-GLYCOLIDE) RESORBABLE FIXATION SY——
Frueh Verpackungstechnik AGSwitzerlandMakerCraniofacial Plate and Screw System · Neuro Plate and Screw System——
Kontour (Xi'an) Medical Technology Co., Ltd.ChinaMakerBIOMESH · Bioplate Rigid Fixation System · Modification to Bioplate Rigid Fixation System · Modified Screw Design · +2——
ARCH Medical Solutions - Escondido LLCUnited StatesMakerPLATE, BONE——
Sphinx Tools LtdSwitzerlandMakerCMF Medicon Surgical Inc——
Eptam West LLCUnited StatesMakerJEY - PLATE, BONE——
Quintus, Inc.United StatesMaker3MM CARBON FIBER ROD——
Matrix Surgical Holdings, LLC. dba Matrix Surgical USAUnited StatesMakerOMNIPORE DUROMAX Surgical Implants · OMNIPORE DUROMAX ZB Orbital Implant——
General Machine, Inc.United StatesMakerDevice-01——
Acumed LLCUnited StatesMaker———
Arctic Biomaterials OyFinlandMaker———
Autocam MedicalUnited StatesMaker———
BEMOTEC GmbHGermanyMaker———
DIENER & RAPP GmbH & Co. KGGermanyMaker———
DOT GmbHGermanyMaker———
KLS Martin Manufacturing, LLCUnited StatesMaker———
Laser Integration Laser Applikation GmbHGermanyMaker———
BioHorizons Implant Systems, Inc.United StatesManufacturer for exportMINIBONEPLATE SYSTEM412026
Young Innovations IncUnited StatesContract manufacturerSalvin Titanium Mesh232025
Suncoast Dental Corp.United StatesRepacker / relabelerTatum Surgical21981
Aesculap, Inc.United StatesLister—22006
Sotera Health LLCUnited StatesContract manufacturerACCESS PORT W / STABILITY 3/5 X 70MM · Bioplate Sterile Kits · Macropore FX, PS, NS, LP · Macropore MX Mandibular Fixation System · +73——
STERIS CorporationUnited StatesContract sterilizerSynthes8894 (DK) - POLY (L-LACTIDE-CO-GLYCOLIDE) RESORBABLE FIXATION SYSTEM; SYNTHES (USA) RAPID RESORBABLE FIXATION SYS · Synthes8894 (DK) -POLY (L-LACTIDE-CO-GLYCOLIDE) RESORBABLE FIXATION SYSTEM; SYNTHES (USA) RAPID RESORBABLE FIXATION SYS · UnicareBiomed3455 (NT) Cytoflex mesh——
Exel Inc. dba DHL Supply Chain (USA)United StatesRepacker / relabelerDePuy Synthes 2.4mm Ti Self-Tapping MatrixMANDIBLE Screws (26-40mm) · MATRIXWAVE MMF SYSTEM · MAXILLARY DISTRACTOR · Synthes (U.S.A) Resorbable Fixation System · +30——
BBF Sterilisationsservice GmbHGermanyContract manufacturerKLS Martin Resorb-X G (Oral Max) · KLS Martin Rigid Fixation - Sterile · PLATE, BONE · SonicWeld RX (Resorb-X) · +1——
HANSAMED LIMITED dba CITAGENIXCanadaForeign exporterCitagenix——
Steritec Services LLCUnited StatesContract sterilizerdental bone plate——
GAMMATOM SrlItalyContract sterilizer———

510(k) clearances

Decided510(k)DeviceApplicant
17 Aug 2026K260137KLS Martin IPS Oral-Max Implants - MR Conditional; Individual Patient Solutions - Ti (IPS-Ti); Individual Patient Solutions - PEEK (IPS-PEEK); KLS Martin Individual Patient SolutionsKLS Martin SE & Co. KG
25 Jul 2026K253206METICULY Patient-specific CMF solutionMeticuly Co., Ltd.
2 Apr 2026K252246Leforte MMF SystemJeil Medical Corporation
19 Dec 2025K253373Southern Craniomaxillofacial (CMF) SystemSouthern Medical (Pty) Ltd
7 Nov 2025K251441Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation SystemBeijing Naton Technology Group Co. Ltd.
16 Aug 2024K241314KLS Martin Oral-Max Implants MR Conditional (bundled)KLS Martin SE & Co. KG
12 Jul 2024K240651MRI UniversalStryker
11 Jul 2024K233874tmCMF SolutionTechmah Cmf
30 Apr 2024K232889METICULY Patient-specific titanium maxillofacial mesh implantMeticuly Co., Ltd.
13 Jan 2024K232350Stryker Facial iD SystemStryker Craniomaxillofacial
26 Sep 2023K230398MedCAD® AccuPlate® 3DTi Patient-Specific Plating SystemMedCAD
5 Aug 2023K230733Stryker Resorbable Fixation SystemStryker
9 Dec 2022K222650Stryker Cutomized Mandible Recon Plate; Stryker Surgeon iD Mandible Recon PlateStryker Craniomaxillofacial (Cmf)
10 Nov 2022K220360Tandry CMF Plate SystemMicroware Precision Co., Ltd.
9 Nov 2022K221855Universal CMF SystemStryker
18 Jul 2022K210731KLS Martin Individual Patient SolutionsKLS Martin SE & Co. KG
4 Feb 2022K213777Stryker Resorbable Fixation SystemStryker Leibinger Micro Implants
5 Aug 2021K202969Biomet Microfixation OmniMax MMF SystemBiomet Microfixation
14 Jul 2021K202918OsteoSync™ Ti Dental MeshSites Medical, LLC
19 May 2021K203282TECHFIT Patient-Specific Maxillofacial SystemIndustrias Medicas Sampedro S.A.S
12 Feb 2021K193280MedCAD® AccuPlate® Patient-Specific PlateMedCAD
10 Sep 2020K201944DePuy Synthes 2.4mm Ti Self-Tapping MatrixMANDIBLE Screws (26-40mm)SYNTHES (USA) Products LLC
29 Jul 2020K182759BoniPlus Dental G-Mesh SystemMontjade Engineering Co., Ltd.
17 Jun 2020K192747Yxoss CBR®ReOss GmbH
22 Apr 2020K191997FAICO CMF SystemFaico Medical, LLC
26 Mar 2020K193143Stryker Facial iD Plating SystemStryker
26 Mar 2020K193136Stryker Customized Mandible Recon Plate KitStryker
30 Dec 2019K192655Depuy Synthes Maxillofacial Portfolio - MR ConditionalSYNTHES (USA) Products LLC
5 Dec 2019K182758MCI - CMF SystemMci Medical Concept Innovation, Inc.
22 Nov 2019K191028KLS Martin Individual Patient SolutionsKLS Martin SE & Co. KG
28 Jun 2019K190696Stryker Surgeon iD Mandible Recon PlateStryker
29 Mar 2019K182609Delphos Implants Rigid Fixation SystemDelphos Implants - Ind.Com. Importacao E Exportacao DE
7 Jan 2019K182305Stryker Facial iD Plating SystemStryker
28 Dec 2018K180204CranioMaxillofacial Fixation (CMF) System - CMF VisionareVisionare LLC
11 Oct 2018K180249OmniPore DUROMAX Surgical ImplantsMatrix Surgical Holdings, LLC/Matrix Surgical USA
13 Aug 2018K180962KLS Martin Individual Patient SolutionsKLS Martin SE & Co. KG
10 Jul 2018K173039TruMatch CMF Titanium 3D Printed ImplantMaterialise NV
24 May 2018K170697GBR systemSurgident Co., Ltd.
26 Mar 2018K172354OssBuilder SystemOsstem Implant Co., Ltd.
23 Feb 2018K173320KLS Martin L1 MMF SystemKLS Martin SE & Co. KG
21 Nov 2017K163579KLS Martin Individual Patient SolutionsKLS Martin SE & Co. KG
8 Nov 2017K170773Stryker Universal MeshStryker
31 Oct 2017K172572Stryker Upper-Face AXS screws and Mid-Face AXS screwsStryker
8 Aug 2017K170272TruMatch CMF Titanium 3D Printed Implant SystemMaterialise NV
24 Jul 2017K171364MP LeFort I PlatesStryker
20 Oct 2016K160363OPTIMUS CMF SYSTEMOSTEONIC Co., Ltd.
10 Dec 2015K152326Biomet Microfixation OmniMax MMF SystemBiomet Microfixation
17 Sep 2015K150965LeForte System IIJeil Medical Corporation
10 Jun 2015K143730GBR SystemJeil Medical Corporation
5 May 2015K142568Stryker MEDPOR TITAN 3D Orbital Floor ImplantStryker
1 Apr 2015K143338Argulated Locking PlatesOsteomed, LLC
1 Apr 2015K143336Biomet Microfixation OmniMax MMF SystemBiomet Microfixation
20 Jan 2015K140037OPTIMUS CMF SYSTEMOSTEONIC Co., Ltd.
18 Dec 2014K141764TRISTAR BONE GRAFT FIXATION SYSTEMImpladent , Ltd.
18 Dec 2014K140978OSTEOMED LOW PROFILE ORBITAL FLOOR PLATE SYSTEMOsteomed, LLC
17 Oct 2014K141165MATRIXWAVE MMF SYSTEMSYNTHES (USA) Products LLC
1 Aug 2014K133461STRYKER UNIVERSAL ORBITAL FLOOR SYSTEMStryker
15 May 2014K133304RXG DISTRACTION SYSTEMKLS Martin SE & Co. KG
9 Jan 2014K121235LEIBINGER ADVANCE INTERNAL MIDFACE DISTRACTION SYSTEMStryker
6 Dec 2013K132519STRYKER CUSTOMIZED MANDIBLE RECON PLATE KITStryker
2 Oct 2013K132600FACIAL PREBENT PLATING WITH VIRTUAL SURGICAL PLANNINGBiomet Microfixation
25 Sep 2013K131289I-GENMegagen Implant Co., Ltd.
18 Sep 2013K130840SMARTBUILDER SYSTEM (SB1)Osstem Implant Co., Ltd.
8 Aug 2013K131674PREBENT PLATING WITH VIRTUAL SURGICAL PLANNINGBiomet Microfixation
9 Apr 2013K123786STRYKER UNIVERSAL ORBITAL FLOOR SYSTEMStryker
28 Feb 2013K122647SYNTHES PATIENT SPECIFIC PLATESYNTHES GMBH / Synthes Produktions GmbH
29 Jan 2013K122890INION CPS ORBITAL PLATESBeijing Naton Technology Group Co. Ltd.
19 Nov 2012K113567SYNTHES MATRIXMADIBLE PLATE AND SCREW SYSTEMSYNTHES GMBH / Synthes Produktions GmbH
31 Oct 2012K122313STRYKER UNIVERSAL SMARTLOCK HYBRID MMF SYSTEMStryker
3 Oct 2012K120951SMARTBUILDER SYSTEMOsstem Implant Co., Ltd.
21 Sep 2012K121589BIOMET MICROFIXATION FACIAL PLATING SYSTEMBiomet Microfixation
29 Jun 2012K121574SYNTHES MATRIXMADIBLE PLATE AND SCREW SYSTEMSYNTHES GMBH / Synthes Produktions GmbH
29 Jun 2012K113512BIOMET MICROFIXATION MANDIBULAR FRACTURE/ RECONSTRUCTION DEVICES AND PREBENT PLATES SYSTEMBiomet Microfixation
30 May 2012K120271ARTISAN SPACE MAINTENANCE SYSTEMMedtronic, Inc.
18 May 2012K112457LEFORTE SYSTEM BONE PLATE & SCREWArkin Consulting Group
23 Mar 2012K112064RESORB X-GKLS Martin SE & Co. KG
10 Jan 2012K111761NEO TITANIUM MESH, CTI-MEMNeobiotech Co., Ltd.
21 Dec 2011K113251SYNTHES MATRIXMANDIBLE PERFORMED RECONSTRUCTION PLATESSYNTHES GMBH / Synthes Produktions GmbH
8 Dec 2011K110926BONE PLATE; BONE SCREWBiomaterials Korea, Inc.
13 Apr 2011K110259ARCHITEX SPACE MAINTENANCE SYSTEMMedtronic, Inc.
18 Mar 2011K103136SURGICASE CMF, SURGICASE CONNECT, SURGICASE GUIDEMaterialise NV
26 Jan 2011K103778LEFORTE NEURO SYSTEM BONE PLATEJeil Medical Corporation
20 Dec 2010K102656SYNTHES DENTOALVEOLAR BONE FIXATION SYSTEMSynthes (Usa)
20 Dec 2010K102641MINI AND MICRO FRAGMENTS RECONSTRUCTION SYSTEM-NEOFACENEOORTHO Produtos Ortopedicos S/A
13 Dec 2010K100779SUSTAIN SPACE MAINTENANCE SYSTEMMedtronic, Inc.
28 Jun 2010K091807MEDPOR FIXATION SYSTEMPorex Surgical, Inc.
7 May 2010K091812FRONTIER DEVICES CRANIOMAXILLOFACIAL, CRANIO CLOSURE, ORTHOGNATHIC, MANDIBLE RECONSTRUCTION AND MESH SYSTEMSFrontier Devices, Inc.
15 Jan 2010K092743THE LEIBINGER ADVANCE INTERNAL MIDFACE DISTRACTION SYSTEMStryker Craniomaxillofacial
11 Dec 2009K091233SYNTHES MATRIXMANDIBLE SUBCONDYLAR PLATESSynthes (Usa)
2 Oct 2009K091679LEFORTE SYSTEM BONE PLATEJeil Medical Corporation
25 Aug 2009K091144SYNTHES MATRIXMANDIBLE PREFORMED RECONSTRUCTION PLATESSynthes (Usa)
12 Mar 2009K083388SYNTHES MATRIXORTHOGNATHIS FIXATION SYSTEMSynthes (Usa)
10 Nov 2008K082335SYNTHES MATRIXMANDIBLE PLATE AND SCREW SYSTEMSynthes (Usa)
29 Oct 2008K073307MAX-FACE MAXILLOFACIAL OSTEOSYNTHESIS SYSTEMBio-Technology USA, Inc.
1 Oct 2008K082757MODIFIED STERILE PLATE & SCREW KIT CONFIGURATIONS FOR USE WITH BIOPLATE TITANIUM FIXATION SYSTEMBioplate, Inc.
21 Jul 2008K080862SONICWELD RX (RESORB-X)KLS Martin SE & Co. KG
15 May 2008K080694OSTEOMED MODULAR LOCKING FIXATION SYSTEMOsteomed, LLC
9 May 2008K081067FRACTURE/RECONSTRUCTION SYSTEM (TRAUMAONE)Biomet Microfixation
30 Apr 2008K080331SYNTHES CRANIOFACIAL PLATE AND SCREW SYSTEMSynthes (Usa)
28 Dec 2007K072528ADJUSTABLE BONE PLATES BIOABSORBABLE, SELF COMPRESSION BONE FIXATION SYSTEM & ACCESSORIESProsurg, Inc.
29 Nov 2007K072463SATYRNE INTERFLEX MANDIBULAR FIXATION SYSTEMSatyrne Medical
11 Sep 2007K071612MODUS TRILOCK 2.0/2.3/2.5Medartis AG
30 Jul 2007K062436SIS SINUS IMPLANT STABILIZERMondeal Medical Systems GmbH
25 Jul 2007K070737XSORB BIOABSORBABLE CRANIOFACIAL BONE FIXATION SYSTEM & ACCESSORIESProsurg, Inc.
16 Apr 2007K063790THE SYNTHES MATRIXMANDIBLE PLATE AND SCREW SYSTEMSynthes (Usa)
14 Mar 2007K061881OSTEOTRANS -MX BIOABSORBABLE BONE FIXATION SYSTEMTakiron Co., Ltd.
27 Feb 2007K062789SYNTHES (USA) RAPID RESORBABLE FIXATION SYSTEMSynthes (Usa)
12 Jan 2007K063052LORENZ TITANIUM FRACTURE / RECONSTRUCTION DEVICES AND PRE-BENT PLATESWalter Lorenz Surgical, Inc.
21 Sep 2006K061507SONICWELD RX ENDOBROW FIXATIONKLS Martin SE & Co. KG
18 Apr 2006K060177KLS MARTIN RIGID FIXATION - STERILEKLS Martin SE & Co. KG
7 Apr 2006K060492AESCULAP CRANIOFACIAL PLATE AND SCREWAesculap, Inc.
20 Sep 2005K052444INION CPS BABY 1.5 BIOABSORBABLE FIXATION SYSTEMBeijing Naton Technology Group Co. Ltd.
22 Aug 2005K051236RESORB-X SFKLS Martin SE & Co. KG
27 Jul 2005K051845THE BIOPLATE RESORBABLE ENDOBROW FIXATION SYSTEMBioplate, Inc.
14 Jun 2005K051293CRANION CRANIAL FIXATION SYSTEM; FIXLOCK; CRANIAL SOLUTIONS; CEREMED FIXATION SYSTEMCeremed , Inc.
27 May 2005K051341INION CPS BABY 1.5 BIOABSORBABLE FIXATION SYSTEM, 40 AND 64 HOLE PLATES, MODELS PLT-1058 AND PLT-1059Beijing Naton Technology Group Co. Ltd.
26 May 2005K050669JEIL BONE FIXATION SYSTEMJeil Medical Corporation
18 May 2005K050608SYNTHES CARNIOFACIAL PLATE AND SCREW SYSTEMSynthes (Usa)
5 May 2005K050934MODUS TITANIUM OSTEOSYNTHESIS SYSTEMMedartis AG
4 Mar 2005K050204SYNTHES RAPID RESORBABLE TACK SYSTEMSynthes (Usa)
23 Feb 2005K043297MEDICON 2.4 MANDIBULAR RECONSTRUCTION PLATING SYSTEMMedicon EG
23 Nov 2004K042987MODIFICATION TO SYNTHES CRANIAL PLATESSynthes (Usa)
18 Nov 2004K042365SYNTHES (USA) NEURO PLATE AND SCREW SYSTEMSynthes (Usa)
8 Oct 2004K042517BIOSORB FX AND BIOSORB PDX 1.5 AND 2.0 SCREWSLinvatec Biomaterials, Ltd.
3 Jun 2004K040650BONAMATES SERIESBiotech One, Inc.
14 May 2004K030425LORENZ RESORBABLE DISTRACTION SYSTEM OR EXPANDERWalter Lorenz Surgical, Inc.
21 Apr 2004K033092THE GNATHOMETEROrtho Gnathics, LLC
1 Apr 2004K030989OSTEOSORB TACK FIXATION SYSTEMNoviace Corporation
23 Feb 2004K040272SYNTHES (USA) CRANIOFACIAL PLATESSynthes (Usa)
12 Nov 2003K032520ORTRAUTEK TRAUMA SYSTEMTekka
30 Oct 2003K033194INION CPS BABY 1.5 BIOABSORBABLE SYSTEMBeijing Naton Technology Group Co. Ltd.
28 Oct 2003K031989ORTRAUTEK ORTHOGNATHIC SYSTEMTekka
20 Oct 2003K0331211.3 & 1.5MM CONTOURABLE TITANIUM (TI.) MESH PLATESSynthes (Usa)
9 Oct 2003K033160SYNTHES STERILE LOW PROFILE NEURO CONTOURABLE MESH PLATESSynthes (Usa)
10 Sep 2003K031659UNIVERSAL NEURO SYSTEMStryker
3 Sep 2003K031761SYNTHES (USA) NEW/STERIAL ORBITAL PLATESSynthes (Usa)
9 May 2003K030448OSTEOMED 2.0 LOCKING PLATES AND SCREWSOsteomed, LLC
28 Apr 2003K031028THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERYBioplate, Inc.
8 Apr 2003K030806BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERYBioplate, Inc.
8 Apr 2003K030069SYNTHES POLY (L-LACTIDE-CO-GLYCOLIDE) RESORBABLE FIXATION SYSTEMSynthes (Usa)
17 Jan 2003K022035OSTEOMEDICS RESORBABLE SMALL FIXATION SYSTEM, OSTEOSORBOsteomedics, Inc.
7 Jan 2003K022844SYNTHES RESORBABLE CONTOURABLE MESHSynthes (Usa)
17 Dec 2002K022185UNIVERSAL CMF SYSTEMStryker
4 Dec 2002K023810MODIFICATION TO BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERYBioplate, Inc.
22 Nov 2002K023665MODIFICATION TO BIOPLATE RIGID BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERYBioplate, Inc.
1 Nov 2002K022012SYNTHES LOW PROFILE NEURO SYSTEMSynthes (Usa)
31 Oct 2002K023488OSSTAPLE, CRANIOFACIALBiomedical Enterprises, Inc.
31 Oct 2002K023486OSSTAPLE, MAXILLOFACIALBiomedical Enterprises, Inc.
6 Sep 2002K022890MODIFIED SCREW DESIGNS FOR USE WITH THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERYBioplate, Inc.
6 Sep 2002K021928SYNTHES (USA) RESORBABLE FIXATION SYSTEMSynthes (Usa)
3 Sep 2002K022005SYNTHES MIDFACE DISTRACTORSynthes (Usa)
14 Aug 2002K021642SYNTHES CRANIOFACIAL PLATESSynthes (Usa)
8 Aug 2002K021618OSA RIGID INTERNAL FIXATION SYSTEMOsteomed, LLC
6 Aug 2002K021511CYTOFLEX MESHUnicare Biomedical, Inc.
1 Aug 2002K021342NORMED BI-DIRECTIONAL/MULTIDIRECTIONAL JAW DISTRACTOROsteomedics, Inc.
1 Aug 2002K021341NORMED BONE TRANSPORT DISTRACTION DEVICEOsteomedics, Inc.
19 Jul 2002K022033STERILE PLATE & SCREW KIT CONFIGURATIONS FOR USE WITH THE BIOPLATE TITANIUM FIXATION SYSTEMBioplate, Inc.
26 Jun 2002K021684THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERYBioplate, Inc.
16 May 2002K021382SYNTHES (USA) AUTOMATED TACK DRIVERSynthes (Usa)
23 Apr 2002K020505SYNTHES TRANSLATING MAXILLARY DISTRACTORSynthes (Usa)
8 Apr 2002K013672BRUGES DISTRACTION - ANCHORING - OSTEOSYNTHESIS SYSTEMAzary Technologies, LLC
20 Mar 2002K011590RESORB-X RESORBABLE PLATING SYSTEMKLS Martin SE & Co. KG
8 Mar 2002K014263NEWGEN/UNIVERSAL MANDIBULAR SYSTEMStryker
22 Feb 2002K011569BIOSORBFX O/M 2.0/2/4 SYSTEMBionx Implants, Inc.
20 Feb 2002K020087SYNTHES CRANIAL PLATESSynthes (Usa)
7 Dec 2001K013055THE BIOPLATE BIOCLIP CRANIOTOMY FIXATION SYSTEMBioplate, Inc.
20 Nov 2001K012910THE BIOPLATE MANDIBLE FIXATION SYSTEMBioplate, Inc.
5 Oct 2001K013039INION CPS 2.0 ORTHOGNATHIC PLATEBeijing Naton Technology Group Co. Ltd.
18 Sep 2001K012413MACROPORE FX, PS, NS, LPMacropore Biosurgery, Inc.
23 Aug 2001K011698STRAUMANN GBR SYSTEMInstitut Straumann AG
14 Aug 2001K010118NORMED MANDIBULAR FIXATION SYSTEMOsteomedics, Inc.
7 Aug 2001K003281LACTOSORB RAPIDFLAPZimmer Inc
11 Jul 2001K002207MACROPOREPX PEDIATRIC SYSTEMMacropore Biosurgery, Inc.
14 May 2001K011380MODIFICATION TO THE BIOPLATE BIOCLIP CRANIOTOMY FIXATION SYSTEMBioplate, Inc.
3 May 2001K010499SYNTHES (USA) MIDFACE DISTRACTORSynthes (Usa)
15 Mar 2001K010351INION CPS BABY 1.5 BIOABSORBABLE FIXATION SYSTEMBeijing Naton Technology Group Co. Ltd.
14 Mar 2001K010687BIOSORBFX AND BIOSORBPDX MESHBionx Implants, Inc.
14 Mar 2001K010352CPS 1.5/2.0/2.5 BIOABSORBABLE FIXATION SYSTEMBeijing Naton Technology Group Co. Ltd.
27 Feb 2001K003786SMF RESORBABLE MESHES AND SHEETSSynthes (Usa)
15 Feb 2001K003549CODMAN CRANIOSORB ABSORBABLE FIXATION SYSTEM PURPLE RIVETSCodman & Shurtleff, Inc.
12 Feb 2001K002083LORENZ RESORBABLE DISTRACTOR SYSTEMWalter Lorenz Surgical, Inc.
7 Feb 2001K003757THERMOFX MESHBionx Implants, Inc.
26 Jan 2001K002426THE BIOPLATE REGID FIXATION BONE PLATING SYSTEM FOR CRANOMAXILLOFACIAL SURGERYBioplate, Inc.
24 Jan 2001K994060THE BIOPLATE RESORBABLE BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY, BIOLACTATEBioplate, Inc.
23 Jan 2001K003883MOLINA ORBITAL MALAR DISTRACTORKLS Martin SE & Co. KG
17 Jan 2001K003393MAXILLARY DISTRACTORSynthes (Usa)
9 Jan 2001K000560SYNTHES (USA) RESORBABLE TACK SYSTEMSynthes (Usa)
3 Jan 2001K003756BIOSORBFX TACK AND BIOSORBPDX TACK BIOABSORBABLE FIXATION FASTENER, USED WITH PLATESBionx Implants, Inc.
12 Dec 2000K003660LEIBINGER NEURO CLIP SYSTEMStryker
8 Dec 2000K000594LOCKING SCREW MANDIBULAR RECONSTRUCTION PLATEStryker Leibinger
6 Dec 2000K002798CODMAN CRANIOSORB ABSORBABLE FIXATION SYSTEM DRILL BITSCodman & Shurtleff, Inc.
16 Nov 2000K002619NEWGEN SYSTEMStryker
19 Oct 2000K000696MACROPOREMX MANDIBULAR FIXATION SYSTEMMacropore Biosurgery, Inc.
5 Oct 2000K002879MODIFICATION TO BIOPLATE BIOCLIP CRANIOTOMY FIXATION SYSTEMBioplate, Inc.
1 Aug 2000K992905CODMAN CRANIOSORB ABSORBABLE FIXATION SYSTEMCodman & Shurtleff, Inc.
21 Jul 2000K001530THE BIOPLATE BIOCLIP CRANIOTOMY FIXATION SYSTEMBioplate, Inc.
21 Jun 2000K001219MEMOGRAPH; OSSTAPLE - ORAL AND MAXILLIOFACIAL PROCEDURES FOR THE MEMOGRAPH STAPLE SYSTEMBiomedical Ent., Inc.
8 Jun 2000K000836BIOSORBPDX BIOABSORBABLE FIXATION SYSTEMBionx Implants, Inc.
3 May 2000K001238LORENZ TITANIUM FRACTURE / RECONSTRUCTION PLATING SYSTEMWalter Lorenz Surgical, Inc.
15 Feb 2000K994154MOD LINE OF MOLINA DISTRACTORS, 51-600 SERIESKLS Martin SE & Co. KG

Showing the 200 most recent of 294.

Official records: FDA product classification for JEY · 21 CFR 872.4760.

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026