510(k) K842234 ยท KWL Prosthesis, Hip, Hemi-, Femoral, Metal
NEW JERSEY FEMORAL STEM
| Applicant | Endomedics, Inc., Walker MI, US |
| Decision | Substantially Equivalent, Jul 20, 1984 |
| Received | Jun 5, 1984 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K842234
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 20, 2010 | Endotec, Inc. Endotec Prothesis Ankle, Titanium Alloy, Sterilized.
BP Ankle System, Talar Ankle Component:
Size 2 Talar Component Catalog: 05-01-0002,
Size 3 Talar Component Catalog: 05-01-0003,
Size 4 Talar Com Terminated |
JWH | None listed |
| May 20, 2010 | Endotec, Inc. Endotec Prothesis Ankle, Titanium Alloy, Sterilized, BP Ankle System.
BP Ankle System, F-P Type III Ankle Bearing Component:
2x5mm F-P Type III Ankle Bearing Catalog: 05-13-0532,
2x7mm F-P Type III Terminated |
JWH | None listed |
| May 20, 2010 | Endotec, Inc. Endotec Prothesis Ankle, Titanium Alloy, Sterilized, BP Ankle System.
BP Ankle System, B-P Type II Talar Ankle Component:
Size 1 B-P Type II Talar Ankle Component Catalog: 05-01-0101,
Size 2 B-P Ty Terminated |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.