510(k) K923807 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
P.F.C. MODULAR TOTAL KNEE SYSTEM, MODULAR PLUS
| Applicant | Johnson & Johnson International, Raynham MA, US |
| Decision | Substantially Equivalent, Nov 9, 1992 |
| Received | Jul 29, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K923807
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 24, 2004 | Depuy Orthopaedics, Inc. P.F.C. Modular Knee System
Modular Plus Tibial Wedge
10 HEMI x 8.5MM HEIGHT
Product Code: 86-0178 Terminated |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.