510(k) K963117 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
P.F.C. CRUCIATE RETAING KNEE SYSTEM
| Applicant | Johnson & Johnson Professionals, Inc., Raynham MA, US |
| Decision | Substantially Equivalent, Nov 6, 1996 |
| Received | Aug 12, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K963117
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 6, 2007 | Depuy Orthopaedics, Inc. Depuy P.F.C. E Knee System Stabilized Plus Tibial Insert (STAB PLUS), 71 mm M/L, 47 mm A/P, 10 mm, 3, UHMWPE, sterile; Product Code/REF 96-2730. Terminated |
NJL | None listed |
| Dec 6, 2007 | Depuy Orthopaedics, Inc. Depuy P.F.C. E Knee System Stabilized Plus Tibial Insert (STAB PLUS), 71 mm M/L, 47 mm A/P, 12.5 mm, 3, UHMWPE, sterile; Product Code/REF 96-2731. Terminated |
NJL | None listed |
| Dec 6, 2007 | Depuy Orthopaedics, Inc. Depuy P.F.C. E Knee System Stabilized Plus Tibial Insert (STAB PLUS), 71 mm M/L, 47 mm A/P, 15 mm, 3, UHMWPE, sterile; Product Code/REF 96-2732. Terminated |
NJL | None listed |
| Dec 6, 2007 | Depuy Orthopaedics, Inc. Depuy P.F.C. E Knee System Stabilized Plus Tibial Insert (STAB PLUS), 71 mm M/L, 47 mm A/P, 17.5 mm, 3, UHMWPE, sterile; Product Code/REF 96-2733. Terminated |
NJL | None listed |
| Dec 6, 2007 | Depuy Orthopaedics, Inc. Depuy P.F.C. E Knee System Stabilized Plus Tibial Insert (STAB PLUS), 71 mm M/L, 47 mm A/P, 25 mm, 3, UHMWPE, sterile; Product Code/REF 96-2736. Terminated |
NJL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.