510(k) K252755 ยท OLO Orthopedic Stereotaxic Instrument
POINT Kinguide Agile Robotic Arm Surgical Stereotactic System
| Applicant | Point Robotics MedTech, Inc., New Taipei City, TW |
| Decision | Substantially Equivalent, Jan 23, 2026 |
| Received | Aug 29, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252755
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.