510(k) K863668 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
OMNIFIT (TM) TOTAL KNEE PROSTHESIS SYSTEM
| Applicant | Osteonics Corp., Allendale NJ, US |
| Decision | Substantially Equivalent for Some Indications, Dec 19, 1986 |
| Received | Sep 18, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K863668
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 31, 2024 | Howmedica Osteonics Corp. SCORPIO RECESSED PATELLA- Intended for Knee Replacement
Part Number: 3044-0026 Open, Classified |
JWH | None listed |
| Jan 31, 2024 | Howmedica Osteonics Corp. SCORPIO RECESSED PATELLA- Intended for knee replacement
Part Number: 3044-0028 Open, Classified |
JWH | None listed |
| Jan 31, 2024 | Howmedica Osteonics Corp. SCORPIO RECESSED PATELLA- Intended for knee replacement
Part Number: 3044-0030 Open, Classified |
JWH | None listed |
| Jan 31, 2024 | Howmedica Osteonics Corp. SCORPIO RECESSED PATELLA-Intended for knee repalcment
Part Number: 3044-0032 Open, Classified |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.