510(k) K163379 ยท OLO Orthopedic Stereotaxic Instrument
KneeAlign 2 System
| Applicant | Orthalign, Inc., Aliso Viejo CA, US |
| Decision | Substantially Equivalent, Mar 2, 2017 |
| Received | Dec 1, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K163379
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.