510(k) K223301 ยท OLO Orthopedic Stereotaxic Instrument
ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments System
| Applicant | Spinecraft, LLC, Westmont IL, US |
| Decision | Substantially Equivalent, Jul 20, 2023 |
| Received | Oct 27, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K223301
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.