510(k) K012788 ยท KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
VAPORIZED HYDROGEN PEROXIDE (VHP) STERILIZATION OF UNMWPE COMPONENTS IN THE COFIELD TOTAL SHOULDER SYSTEM, THE NEER II
| Applicant | Smith & Nephew, Inc., Memphis TN, US |
| Decision | Substantially Equivalent, Mar 15, 2002 |
| Received | Aug 20, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012788
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.