510(k) K222355 ยท OLO Orthopedic Stereotaxic Instrument
PathKeeper System
| Applicant | Pathkeeper Surgical , Ltd., Kfar-Saba, IL |
| Decision | Substantially Equivalent, Mar 8, 2023 |
| Received | Aug 4, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K222355
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.