Manufacturer registered with FDA
DePuy Synthes, Inc.
Warsaw, IN, United States. Lists 6 dental device types with FDA across 2 registered establishments.
- Device types listed
- 6
- Brands and models
- 11
- 510(k) clearances
- 0as applicant
- Markets registered in
- 7210 registrations outside the US
- Establishments
- 2United Kingdom, United States
Registered in 7 markets
Where regulators' registries name DePuy Synthes, Inc. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | DePuy Synthes, Inc. | 6 device types | — | Below |
| Colombia | INVIMA | Manufacturer | DEPUY ORTHOPAEDICS INC.DEPUY ORTHOPAEDICS INC · DEPUY ORTHOPAEDICS, INC · +2 | 84 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | DEPUY ORTHOPAEDICS,INC.DEPUY ORTHOPAEDICS, INC. · DePuy Orthopaedics,Inc. · +1 | 44 | 1993–2023 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | DEPUY ORTHOPAEDICS INCDEPUY ORTHOPAEDICS, INC. | 41 | 1997–2021 | Pure Global AI |
| Peru | DIGEMID | Manufacturer | DEPUY ORTHOPAEDICS, INCDEPUY ORTHOPAEDICS INC | 28 | 2011–2024 | Pure Global AI |
| Israel | AMAR | Manufacturer | DePuy CMWDePuy Orthopaedics Inc. · DePuy Orthopaedics, Inc. | 10 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | DePuy CMW | 3 | 1998–1998 | 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
Devices listed with FDA
What DePuy Synthes, Inc. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Bone PlateJEY · Class 2 | Maxillofacial plates & screws | Maker | MAXILLARY DISTRACTORSYNTHES (USA) [SYNTHES] MINI EXTERNSYNTHES (USA) RAPID RESORBABLE FIXATION SYSTEMSYNTHES POLY (L-LACTIDE-CO-GLYCOLIDE) RESORBABLE FIXATION SY | 2023 |
| Powered Bone DrillDZI · Class 2 | Surgical drills & motors | Lister | Synthes 90 Degree Screwdriver | 2023 |
| Manual Wire Driver and Bone DrillDZJ · Class 2 | Surgical drills & motors | Lister | Dental Bone Cutting InstrumentsSynthes 90 Degree Screwdriver | 2023 |
| Intraosseous Fixation ScrewDZL · Class 2 | Maxillofacial plates & screws | Lister | SYNTHES (USA) EXTERNAL MULTI VECTORSYNTHES 1.5MM/2MM ORTHOGNATHIC MA | 2023 |
| Synthetic Bone Grafting MaterialLYC · Class 2 | Bone grafts & membranes | Maker | Symphony | 2016 |
| External Mandibular Fixator and/or DistractorMQN · Class 2 | Maxillofacial plates & screws | Lister | SYNTHES MANDIBLE EXTERNAL FIXATOR | 2023 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
DePuy Synthes, Inc. lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Synthes (Usa) (11), SYNTHES (USA) Products LLC (1), Depuyacromed (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 23 Jun 2015 | K150796 | Dental Bone Cutting Instruments | SYNTHES (USA) Products LLC | DZJ Manual Wire Driver and Bone Drill |
| 30 Apr 2009 | K082649 | SYNTHES 90 DEGREE SCREWDRIVER | Synthes (Usa) | DZI Powered Bone Drill |
| 27 Feb 2007 | K062789 | SYNTHES (USA) RAPID RESORBABLE FIXATION SYSTEM | Synthes (Usa) | JEY Bone Plate |
| 23 Jan 2006 | K053022 | SYNTHES (USA) CHRONOS-BETA-TCP | Synthes (Usa) | LYC Synthetic Bone Grafting Material |
| 15 Mar 2005 | K050378 | SYNTHES MANDIBLE EXTERNAL FIXATOR | Synthes (Usa) | MQN External Mandibular Fixator and/or Distractor |
| 31 Mar 2004 | K040083 | SYNTHES EXTERNAL MIDFACE DISTRACTOR | Synthes (Usa) | MQN External Mandibular Fixator and/or Distractor |
| 8 Apr 2003 | K030069 | SYNTHES POLY (L-LACTIDE-CO-GLYCOLIDE) RESORBABLE FIXATION SYSTEM | Synthes (Usa) | JEY Bone Plate |
| 18 Jan 2001 | K003286 | SYMPHONY GRAFT DELIVERY SYSTEM | Depuyacromed | LYC Synthetic Bone Grafting Material |
| 17 Jan 2001 | K003393 | MAXILLARY DISTRACTOR | Synthes (Usa) | JEY Bone Plate |
| 29 Jun 1998 | K981362 | SYNTHES (USA) EXTERNAL MULTI VECTOR MANDIBLE DISTRACTOR | Synthes (Usa) | DZL Intraosseous Fixation Screw |
| 17 Apr 1998 | K980199 | SYNTHES 1.5MM/2.0MM ORTHOGNATHIC MAXILLARY PLATES AND SCREWS | Synthes (Usa) | DZL Intraosseous Fixation Screw |
| 24 Feb 1998 | K974554 | SYNTHES RESORBABLE FIXATION SYSTEM | Synthes (Usa) | JEY Bone Plate |
| 24 Jun 1997 | K971987 | SYNTHES (USA) [SYNTHES] MINI EXTERNAL FIXATOR | Synthes (Usa) | JEY Bone Plate |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| DEPUY CMWFDA reg. 9610921 | BLACKPOOL, LANCASHIRE, United Kingdom | Manufacturer |
| DEPUY ORTHOPAEDICSFDA reg. 3004464325 | BRIDGEWATER, MA, United States | Repacker / relabeler |
Other names on FDA records
DePuy Orthopaedics,Inc. · DePuy CMW
Sources
FDA establishment registration & device listing (search FDA, owner/operator 1818910). 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.