Depuy, Inc.
Walker, MI, US
Depuy, Inc. appears in FDA device records in Walker, MI. FDA records list 14 510(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
- 14
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 14 510(k) clearances for Depuy, Inc. between 1977 and 1984. The busiest year on record is 1981, with 3. The most recent is 1984, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1977 | 1 |
| 1978 | 2 |
| 1980 | 1 |
| 1981 | 3 |
| 1982 | 2 |
| 1983 | 3 |
| 1984 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K833599 | MODIFIED HPS HIP PROSTHESIS | KWL | Substantially Equivalent | |
| K840286 | BROOKER EXTERNAL FIXATION FRAME | JDW | Substantially Equivalent | |
| K831441 | POROCOAT FREEMAN/SAMUELSON TOTAL KNEE | MBV | Substantially Equivalent | |
| K831314 | INTERFERENCE MEDULLARY FIT -IMF-HIP | JDI | Substantially Equivalent | |
| K830408 | FREEMAN/SAMUELSON TOTAL KNEE | MBV | Substantially Equivalent | |
| K821714 | POROCOAT STANDARD METAL BACKED CUP | JDI | Substantially Equivalent | |
| K821713 | POROCOAT LOW PROFILE METAL BACKED CUP | JDI | Substantially Equivalent | |
| K811557 | DEPUY HEMODRAIN | GCY | Substantially Equivalent | |
| K810326 | POROCOAT TM TOWNLEY ANATOMIC KNEE | JWH | Substantially Equivalent | |
| K802921 | ICLH TIBIAL PLATEAU | MBV | Substantially Equivalent | |
| K802460 | HELFET ELBOW PROSTHESIS | JDB | Substantially Equivalent | |
| K780904 | KNEE, TOTAL, FEMORAL & TIBIAL | MBV | Substantially Equivalent | |
| K780284 | TIBIAL PLATEU | MBV | Substantially Equivalent | |
| K771744 | OSTEOTOMES FOR CUTTING BONH | HWM | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- GCYApparatus, Suction, Single Patient Use, Portable, Nonpowered
- HWMOsteotome
- JDWPin, Fixation, Threaded
- JDBProsthesis, Elbow, Semi-Constrained, Cemented
- KWLProsthesis, Hip, Hemi-, Femoral, Metal
- JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
- MBVProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer
- JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain