Not currently registered with FDA under this name
Synthes (Usa)
West Chester, PA, United States. Named as applicant on 71 dental 510(k) clearances between 1984 and 2010. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 711984–2010
- Markets registered in
- 6165 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 1980–2026
Registered in 6 markets
Where regulators' registries name Synthes (Usa) as the manufacturer or the registration holder of a device.
RegisteredHome: United StatesOne marker per market
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Applicant | Synthes (Usa) | 71 clearances | 1984–2010 | Below |
| Canada | Health Canada | Registration holder | SYNTHES USA LLC | 137 | 1998–2015 | Pure Global AI |
| South Korea | MFDS | Manufacturer | Synthes USA LLCSYNTHES USA LLC · Synthes USA | 13 | 1999–2020 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | SYNTHES USA LLCSYNTHES USA LLC, | 6 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | SYNTHES (USA) | 5 | 2009–2015 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | SYNTHES USA LLC | 4 | — | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
510(k) clearances
Clearances on which FDA names Synthes (Usa) as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 20 Dec 2010 | K102656 | SYNTHES DENTOALVEOLAR BONE FIXATION SYSTEM | JEY Bone Plate |
| 16 Dec 2010 | K093299 | SYNTHES ORTHODONTIC BONE ANCHOR SYSTEM | OAT Orthodontic Endosseous Implant |
| 25 Jan 2010 | K093464 | RAPIDSORB PLUS SCREW SYSTEM | DZL Intraosseous Fixation Screw |
| 11 Dec 2009 | K091233 | SYNTHES MATRIXMANDIBLE SUBCONDYLAR PLATES | JEY Bone Plate |
| 25 Aug 2009 | K091144 | SYNTHES MATRIXMANDIBLE PREFORMED RECONSTRUCTION PLATES | JEY Bone Plate |
| 30 Apr 2009 | K082649 | SYNTHES 90 DEGREE SCREWDRIVER | DZI Powered Bone Drill |
| 12 Mar 2009 | K083388 | SYNTHES MATRIXORTHOGNATHIS FIXATION SYSTEM | JEY Bone Plate |
| 10 Nov 2008 | K082335 | SYNTHES MATRIXMANDIBLE PLATE AND SCREW SYSTEM | JEY Bone Plate |
| 5 Sep 2008 | K081747 | MODIFICATION TO SYNTHES (USA) CONDYLAR HEAD ADD-ON SYSTEM | NEI Temporary Mandibular Condyle Prosthesis |
| 14 May 2008 | K080153 | SYNTHES (USA) CURVILINEAR DISTRACTION SYSTEM | MQN External Mandibular Fixator and/or Distractor |
| 30 Apr 2008 | K080331 | SYNTHES CRANIOFACIAL PLATE AND SCREW SYSTEM | JEY Bone Plate |
| 16 Apr 2007 | K063790 | THE SYNTHES MATRIXMANDIBLE PLATE AND SCREW SYSTEM | JEY Bone Plate |
| 8 Mar 2007 | K063473 | SYNTHES ORTHODONTIC BONE ANCHOR SYSTEM | OAT Orthodontic Endosseous Implant |
| 27 Feb 2007 | K062789 | SYNTHES (USA) RAPID RESORBABLE FIXATION SYSTEM | JEY Bone Plate |
| 5 Jan 2007 | K063181 | SYNTHES (USA) CONDYLAR HEAD ADD-ON SYSTEM | NEI Temporary Mandibular Condyle Prosthesis |
| 31 Aug 2006 | K062299 | SYNTHES STERILE MANDIBLE EXTERNAL FIXATION KIT | MQN External Mandibular Fixator and/or Distractor |
| 2 Jun 2006 | K060138 | SYNTHES (USA) CRANIOMAXILLOFACIAL DISTRACTION SYSTEM | MQN External Mandibular Fixator and/or Distractor |
| 23 Jan 2006 | K053022 | SYNTHES (USA) CHRONOS-BETA-TCP | LYC Synthetic Bone Grafting Material |
| 18 May 2005 | K050608 | SYNTHES CARNIOFACIAL PLATE AND SCREW SYSTEM | JEY Bone Plate |
| 12 Apr 2005 | K043555 | SYNTHES 9USA) ALVEOLAR RIDGE DISTRACTOR | MQN External Mandibular Fixator and/or Distractor |
| 6 Apr 2005 | K050606 | SYNTHES 1.0MM TI. CORTEX, SELF-DRILLING SCREWS (CARNIOFACIAL) | DZL Intraosseous Fixation Screw |
| 15 Mar 2005 | K050378 | SYNTHES MANDIBLE EXTERNAL FIXATOR | MQN External Mandibular Fixator and/or Distractor |
| 4 Mar 2005 | K050204 | SYNTHES RAPID RESORBABLE TACK SYSTEM | JEY Bone Plate |
| 23 Nov 2004 | K042987 | MODIFICATION TO SYNTHES CRANIAL PLATES | JEY Bone Plate |
| 18 Nov 2004 | K042365 | SYNTHES (USA) NEURO PLATE AND SCREW SYSTEM | JEY Bone Plate |
| 19 Aug 2004 | K041887 | SYNTHES (USA) 1.0/1.22 MM CRANIOFACIAL SCREWS | DZL Intraosseous Fixation Screw |
| 14 Apr 2004 | K040169 | SYNTHES MANDIBLE EXTERNAL FIXATOR | MQN External Mandibular Fixator and/or Distractor |
| 31 Mar 2004 | K040083 | SYNTHES EXTERNAL MIDFACE DISTRACTOR | MQN External Mandibular Fixator and/or Distractor |
| 23 Feb 2004 | K040272 | SYNTHES (USA) CRANIOFACIAL PLATES | JEY Bone Plate |
| 29 Oct 2003 | K033065 | SYNTHES 2.0 MM CRANIOFACIAL LOCKING PLATES | MQN External Mandibular Fixator and/or Distractor |
| 20 Oct 2003 | K033121 | 1.3 & 1.5MM CONTOURABLE TITANIUM (TI.) MESH PLATES | JEY Bone Plate |
| 9 Oct 2003 | K033160 | SYNTHES STERILE LOW PROFILE NEURO CONTOURABLE MESH PLATES | JEY Bone Plate |
| 3 Sep 2003 | K031761 | SYNTHES (USA) NEW/STERIAL ORBITAL PLATES | JEY Bone Plate |
| 2 Jul 2003 | K031807 | SYNTHES LOW PROFILE NEURO SYSTEM - 3 MM SCREWS | DZL Intraosseous Fixation Screw |
| 8 Apr 2003 | K030069 | SYNTHES POLY (L-LACTIDE-CO-GLYCOLIDE) RESORBABLE FIXATION SYSTEM | JEY Bone Plate |
| 7 Jan 2003 | K022844 | SYNTHES RESORBABLE CONTOURABLE MESH | JEY Bone Plate |
| 1 Nov 2002 | K022012 | SYNTHES LOW PROFILE NEURO SYSTEM | JEY Bone Plate |
| 6 Sep 2002 | K021928 | SYNTHES (USA) RESORBABLE FIXATION SYSTEM | JEY Bone Plate |
| 3 Sep 2002 | K022005 | SYNTHES MIDFACE DISTRACTOR | JEY Bone Plate |
| 14 Aug 2002 | K021642 | SYNTHES CRANIOFACIAL PLATES | JEY Bone Plate |
| 10 Jun 2002 | K021850 | SYNTHES (USA) 1.3 MM CRANIOFACIAL SCREWS | DZL Intraosseous Fixation Screw |
| 16 May 2002 | K021382 | SYNTHES (USA) AUTOMATED TACK DRIVER | JEY Bone Plate |
| 23 Apr 2002 | K020505 | SYNTHES TRANSLATING MAXILLARY DISTRACTOR | JEY Bone Plate |
| 20 Feb 2002 | K020087 | SYNTHES CRANIAL PLATES | JEY Bone Plate |
| 18 May 2001 | K010690 | SYNTHES TITANIUM MULTI-VECTOR DISTRACTOR | DZL Intraosseous Fixation Screw |
| 3 May 2001 | K010499 | SYNTHES (USA) MIDFACE DISTRACTOR | JEY Bone Plate |
| 25 Apr 2001 | K010527 | SYNTHES (USA) IMF SCREWS | DZL Intraosseous Fixation Screw |
| 27 Feb 2001 | K003786 | SMF RESORBABLE MESHES AND SHEETS | JEY Bone Plate |
| 17 Jan 2001 | K003393 | MAXILLARY DISTRACTOR | JEY Bone Plate |
| 9 Jan 2001 | K000560 | SYNTHES (USA) RESORBABLE TACK SYSTEM | JEY Bone Plate |
| 16 Nov 2000 | K002935 | SYNTHES 1.5MM TI BROW LIFT SCREW | DZL Intraosseous Fixation Screw |
| 22 Oct 1999 | K990637 | SYNTHES LOCKING RECONSTRUCTION PLATE (LRP) WITH CONDYLAR HEAD | NEI Temporary Mandibular Condyle Prosthesis |
| 23 Jun 1999 | K991004 | SYNTHES QUICK LOCK IMF SYSTEM | DYX Intraoral Wire Lock and Ligature |
| 21 Dec 1998 | K983485 | SYNTHES 1.3 MM SELF-DRILLING SCREW | DZL Intraosseous Fixation Screw |
| 18 Aug 1998 | K981890 | SYNTHES (USA) [SYNTHES] MMFS - 2.0 MM SAGITTAL SPLIT PLATES | JEY Bone Plate |
| 29 Jun 1998 | K981362 | SYNTHES (USA) EXTERNAL MULTI VECTOR MANDIBLE DISTRACTOR | DZL Intraosseous Fixation Screw |
| 25 Jun 1998 | K981275 | SYNTHES (USA) RATCHETING DISTRACTOR | MQN External Mandibular Fixator and/or Distractor |
| 22 Jun 1998 | K981075 | SYNTHES (USA) (SYNTHES) SINGLE VECTOR DISTRACTOR WITH DETACHABLE FEET | MQN External Mandibular Fixator and/or Distractor |
| 17 Apr 1998 | K980199 | SYNTHES 1.5MM/2.0MM ORTHOGNATHIC MAXILLARY PLATES AND SCREWS | DZL Intraosseous Fixation Screw |
| 3 Mar 1998 | K974555 | SYNTHES 2.0 MM LOCKING PLATE SYSTEM (2.0 LPS) | JEY Bone Plate |
| 24 Feb 1998 | K974554 | SYNTHES RESORBABLE FIXATION SYSTEM | JEY Bone Plate |
| 10 Nov 1997 | K973018 | SYNTHES MINI LENGTHENING APPARATUS | MQN External Mandibular Fixator and/or Distractor |
| 24 Jun 1997 | K971987 | SYNTHES (USA) [SYNTHES] MINI EXTERNAL FIXATOR | JEY Bone Plate |
| 24 Jun 1997 | K963546 | SMF TITANIUM (TI) ALLOY BONE SCREWS | DZL Intraosseous Fixation Screw |
| 11 Apr 1997 | K964261 | SMF STAINLESS STEEL BONE SCREWS | DZL Intraosseous Fixation Screw |
| 13 Dec 1996 | K964328 | SYNTHES (USA) SYNTHES MMFS-ADJUSTABLE SAGITTAL SPLIT PLATE | JEY Bone Plate |
| 30 Aug 1996 | K962272 | SYNTHES MANDIBLE DISTRACTOR | MQN External Mandibular Fixator and/or Distractor |
| 26 Jun 1996 | K961421 | SYNTHES 2.4 MM UNIVERSAL LOCKING PLATE SYSTEM | JEY Bone Plate |
| 8 Mar 1996 | K954385 | SYNTHES MANDIBULAR MODULAR FIXATION SYSTEM | JEY Bone Plate |
| 8 Mar 1996 | K953806 | SYNTHES (USA) MIDFACIAL SYSTEM | JEY Bone Plate |
| 19 Jun 1984 | K840955 | CONDYLAR PROSTHESIS OF MANDIBLE W/HEAD | JEY Bone Plate |
Some of these clearances are listed with FDA today by another company: SYNTHES (USA) Products LLC (69), SYNTHES GMBH / Synthes Produktions GmbH (56), DePuy Synthes, Inc. (11), The Anspach Effort Inc (1).
Sources
FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record of the most recent filing, which can be a US agent.