510(k) K162237 ยท ONN Intraoperative Orthopedic Joint Assessment Aid
XO1 Knee Balancing System
| Applicant | Xpandortho, Inc., La Jolla CA, US |
| Decision | Substantially Equivalent, Apr 25, 2017 |
| Received | Aug 9, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162237
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.