510(k) K191755 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
SPAR-K Instruments (for use with Gemini SL Total Knee System)
| Applicant | Waldemar Link GmbH & Co. KG, Norderstedt, DE |
| Decision | Substantially Equivalent, Jul 18, 2019 |
| Received | Jul 1, 2019 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K191755
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.