510(k) K170534 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
PROLIXUS TOTAL KNEE SYSTEM
| Applicant | Otis Biotech Co., Ltd., Siheung-Si, KR |
| Decision | Substantially Equivalent, Nov 9, 2017 |
| Received | Feb 23, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K170534
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.