510(k) K230850 ยท OOG Knee Arthroplasty Implantation System
United Orthopedic Knee Patient Specific Instrumentation
| Applicant | Enhatch, Inc., Hasbrouck Heights NJ, US |
| Decision | Substantially Equivalent, Dec 20, 2023 |
| Received | Mar 28, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K230850
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.