510(k) K192911 ยท OLO Orthopedic Stereotaxic Instrument
Brainlab Compatible K2M Navigation Instruments
| Applicant | K2m, Inc., Leesburg VA, US |
| Decision | Substantially Equivalent, Nov 14, 2019 |
| Received | Oct 15, 2019 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K192911
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.