510(k) K971422 ยท MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
OSTEONICS ACETABULAR WEDGE SYSTEM
| Applicant | Osteonics Corp., Allendale NJ, US |
| Decision | Substantially Equivalent for Some Indications, May 22, 1997 |
| Received | Apr 17, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971422
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.