510(k) K252597 ยท OLO Orthopedic Stereotaxic Instrument
Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with StealthStation)
| Applicant | Alphatec Spine, Inc., Carlsbad CA, US |
| Decision | Substantially Equivalent, Feb 19, 2026 |
| Received | Aug 15, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252597
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.