510(k) K971715 ยท KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
SELECT SHOULDER OFFSET HUMERAL HEAD COMPONENTS
| Applicant | Sulzer Orthopedics, Inc., Austin TX, US |
| Decision | Substantially Equivalent, Aug 7, 1997 |
| Received | May 9, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971715
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.