510(k) K023409 ยท LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
HA X-SERIES BI-METRIC HIP FEMORAL COMPONENTS
| Applicant | Biomet, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Nov 8, 2002 |
| Received | Oct 10, 2002 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K023409
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 21, 2019 | Zimmer Biomet, Inc. Various Hip systems, Item Nos. 104207
104212
104215
11-162809
11-162810
11-162811
11-162812
11-162813
21-103202
21-103203
21-103204
21-103205
21-103206
21-103207
21-103208
21-103209
21-103210
21-10321 Terminated |
LPH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.