510(k) K911902 ยท HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
TEMPERLITE(TM) SAW BLADE
| Applicant | Sierra Surgical, Inc., Rancho Cordova CA, US |
| Decision | Substantially Equivalent, Jun 28, 1991 |
| Received | Apr 26, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K911902
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 17, 2013 | Synvasive Technology Inc The Oxford Partial Knee; Oxford Knee Resection Procedure 3 Pack CEMENTED
For use with Stryker System 5, System 4, System 2000 and EDH.
Product Usage: For use with Stryker System 5, System 4, System Terminated |
HSD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.