510(k) K973124 ยท LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
APR POROUS HA HIP SYSTEM
| Applicant | Sulzer Orthopedics, Inc., Austin TX, US |
| Decision | Substantially Equivalent for Some Indications, Nov 3, 1997 |
| Received | Aug 20, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K973124
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 10, 2019 | Zimmer Biomet, Inc. Various Hip Joint Replacement Systems, Item Nos. 00151504232
00151504432
00151504636
00151504836
00151505040
00151505240
00151505444
00151505644
00151505848
00151506048
00151506248
00151506448
0015150 Terminated |
LPH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.