510(k) K011976 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
OPTETRAK TOTAL KNEE SYSTEM SIZE 0/1 DELTA (LINE EXTENSION)
| Applicant | Exactech, Inc., Gainesville FL, US |
| Decision | Substantially Equivalent, Jul 16, 2001 |
| Received | Jun 25, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K011976
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.