510(k) K960425 ยท JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
BUECHEL-PAPPAS POLYETHLENE ACETABULAR COMPONENT(01-42-YYXX & 01-43-YYXX
| Applicant | Endotec, Inc., Bloomfield NJ, US |
| Decision | Substantially Equivalent, Oct 3, 1996 |
| Received | Jan 29, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K960425
| 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.