510(k) K012251 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
OPTETRAK TOTAL KNEE SYSTEM, STRAIGHT STEM EXTENSIONS - ADDITIONAL SIZES
| Applicant | Exactech, Inc., Gainesville FL, US |
| Decision | Substantially Equivalent, Jul 31, 2001 |
| Received | Jul 18, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K012251
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.