510(k) K201519 · JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
PROFEMUR® GLADIATOR® Cemented Classic Stem
| Applicant | Microport Orthopedics, Inc., Arlington TN, US |
| Decision | Substantially Equivalent, Dec 10, 2020 |
| Received | Jun 8, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K201519
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.