510(k) K201006 ยท OLO Orthopedic Stereotaxic Instrument
K2M Navigation Instruments
| Applicant | K2m, Inc., Leesburg VA, US |
| Decision | Substantially Equivalent, Aug 7, 2020 |
| Received | Apr 17, 2020 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K201006
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.