510(k) K143085 ยท LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip Instruments for use with the Direct Superior Approach
| Applicant | Stryker Orthopaedics, Mahwah NJ, US |
| Decision | Substantially Equivalent, Feb 9, 2015 |
| Received | Oct 27, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K143085
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 21, 2017 | Howmedica Osteonics Corp. Accolade and Restoration hip product; Catalog Number: 6720-0837 and 6721-0737 Terminated |
LPH | None listed |
| Jul 21, 2017 | Howmedica Osteonics Corp. Accolade and Restoration hip product; Catalog Number: 6021-0030, 6276-1-127, 6276-5-216, 6020-2530, 6020-4535, 6021-0740, 6021-0230, and 6021-4535 Terminated |
LPH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.