510(k) K993259 ยท LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
INTER-OP DURASUL ACETABULAR INSERTS/COCR FEMORAL HEADS
| Applicant | Sulzer Orthopedics, Inc., Austin TX, US |
| Decision | Substantially Equivalent, Mar 10, 2000 |
| Received | Sep 29, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K993259
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 29, 2023 | Zimmer, Inc. CoCr Femoral Head, XS, 38/-8, Taper 12/14-Intended to be used as a modular head component for articulation in total hip arthroplasty.
Item Number: 01.01012.384 Open, Classified |
LPH | None listed |
| Feb 20, 2015 | Zimmer Gmbh CoCr Femoral Head - A modular head component is used in conjunction with a femoral stem component for replacement of the proximal femur in total hip arthroplasty. Terminated |
LPH | None listed |
| Nov 6, 2012 | Zimmer, Inc. CoCr Head, sterile, Rx Terminated |
JDI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.