Synthes (USA) Products, LLC / Depuy Orthopaedics, Inc.
West Chester, PA, US
Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. appears in FDA device records in West Chester, PA. FDA records list 5 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 5
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 5 510(k) clearances for Synthes (USA) Products, LLC / Depuy Orthopaedics, Inc. between 2017 and 2019. The busiest year on record is 2018, with 2. The most recent is 2019, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2017 | 1 |
| 2018 | 2 |
| 2019 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K192745 | DePuy Synthes Trauma Screws | HWC | Substantially Equivalent | |
| K181933 | DePuy Synthes Sterilization Container System | KCT | Substantially Equivalent | |
| K180310 | DePuy Synthes Trauma Orthopedic Plates and Screws | HRS | Substantially Equivalent | |
| K172975 | DePuy Synthes (USA) 5.0mm / 7.3mm Crimp Positioning Pins – MR Conditional, DePuy Synthes Variable Angle Positioning Pins – MR Conditional, DePuy Synthes Wire Mount – MR Conditional, DePuy Synthes Cerclage Positioning Pin – MR Conditional | JDQ | Substantially Equivalent | |
| K160553 | DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist Fusion Plate (WFP) – MR Conditional, DePuy Synthes Large Fragment Dynamic Compression Locking (DCL) System –MR Conditional, DePuy Synthes Small Fragment Dynamic Compression Locking (DCL) System – MR Conditional, DePuy Synthes Modular Foot System – MR Conditional, DePuy Synthes T-Plates – MR Conditional, DePuy Synthes One-third Tubular Plate with Collar (OTPC) – MR Conditional, DePuy Synthes Stainless S | HRS | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain