510(k) K963101 ยท LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
B-P HEMISPHERICAL ACETABULAR COMPONENT
| Applicant | Endotec, Inc., South Orange NJ, US |
| Decision | Substantially Equivalent, Feb 12, 1997 |
| Received | Aug 9, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K963101
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 20, 2010 | Endotec, Inc. Endotec Prothesis Hip, Titanium Alloy, Sterilized.
Acetabular Bearing, BP Hip System Component:
32x54 Acetabular Bearing, Catalog: 01-02-3254,
32x56 Acetabular Bearing, Catalog: 01-02-3256,
Femora Terminated |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.