510(k) K023357 ยท LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
ARCPM 1050 RESIN-HIPS
| Applicant | Biomet Orthopedics, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Nov 6, 2002 |
| Received | Oct 7, 2002 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K023357
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 27, 2017 | Zimmer Biomet, Inc. various polyethylene implants
Hips
Active Articulation ArComXL Bearings
Active Articulation E1 Bearings
Arcos Taper Cap
BIOLOX delta Option Head
E1 RingLoc Bi-Polar
Freedom Constrained Liner +5mm
Hi Terminated |
JDI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.