510(k) K252989 · OLO Orthopedic Stereotaxic Instrument
POINT Kinguide Agile Hybrid Navigation System; DRF Accessories Set
| Applicant | Point Robotics MedTech, Inc., New Taipei City, TW |
| Decision | Substantially Equivalent, Feb 20, 2026 |
| Received | Sep 18, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252989
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.