510(k) K100048 ยท OIY Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive
E1 ANTIOXIDANT INFUSED TECHNOLOGY
| Applicant | Biomet Manufacturing Corp, Warsaw IN, US |
| Decision | Substantially Equivalent, Mar 9, 2010 |
| Received | Jan 8, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K100048
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.