510(k) K103007 ยท KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
AFFINITI TOTAL AND HEMI-SHOULDER SYSTEM
| Applicant | Tornier, Inc., Beverly MA, US |
| Decision | Substantially Equivalent, Nov 9, 2010 |
| Received | Oct 12, 2010 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K103007
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.