K252989
- 510(k) number
- K252989
- Device name
- POINT Kinguide Agile Hybrid Navigation System; DRF Accessories Set
- Applicant
- Point Robotics MedTech, Inc. TW
- Product code
- OLO — Orthopedic Stereotaxic Instrument
- Decision date
- 2026-02-20
- Date received
- 2025-09-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K252989.pdf
Official FDA record: K252989
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.