510(k) K053505 ยท MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
REGENEREX ULTRA POROUS CONSTRUCT-FEMORAL AND TIBIAL KNEE AUGMENTS
| Applicant | Biomet Manufacturing, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Aug 14, 2006 |
| Received | Dec 16, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K053505
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.