510(k) K122015 ยท KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
DISTAL FEMORAL GROWING PROSTHESIS, TIBIAL ROTATING COMPONENTS, BEARING, AXIS, CIRCLIP, WEDGE
| Applicant | Howmedica Osteonics Corp., Mahwah NJ, US |
| Decision | Substantially Equivalent, Feb 22, 2013 |
| Received | Jul 10, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K122015
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.