510(k) K080842 ยท MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
APEX KNEE SYSTEM, MODEL KC-230XY, KC-240XY [ NO HOLES, 2 HOLES]
| Applicant | Omni Life Science, Inc., Raynham MA, US |
| Decision | Substantially Equivalent, May 23, 2008 |
| Received | Mar 25, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K080842
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.