510(k) K231229 · OLO Orthopedic Stereotaxic Instrument
S-COMP Reform® POCT Navigation Instruments
| Applicant | Precision Spine, Inc., Pear MS, US |
| Decision | Substantially Equivalent, May 25, 2023 |
| Received | Apr 28, 2023 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K231229
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.