510(k) K103829 ยท OLO Orthopedic Stereotaxic Instrument
KNEEALIGN SYSTEM
| Applicant | Orthalign, Inc., Newport Beach CA, US |
| Decision | Substantially Equivalent, Apr 4, 2011 |
| Received | Dec 30, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K103829
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.