510(k) K980711 ยท LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
HARRIS/GALANTE POROUS (HGP) HIP PROSTHESIS WITH CALCICOAT CERAMIC COATING
| Applicant | Zimmer, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Nov 12, 1998 |
| Received | Feb 24, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K980711
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 4, 2013 | Zimmer, Inc. Trilogy F/M Acetabular Shell without holes SOLID HA. Several ODs: 38MM, 40MM, 42MM, 44MM, 46MM, 48MM, 50MM, 52MM, 54MM, 56MM, 58MM, 60MM, 62MM, 64MM, 66MM, 68MM, 70MM.
The Trilogy Acetabular System i Terminated |
MEH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.