K241130
- 510(k) number
- K241130
- Device name
- POINT Kinguide Agile Hybrid Navigation System (PSHF01-000)
- Applicant
- Point Robotics MedTech, Inc. TW
- Product code
- OLO — Orthopedic Stereotaxic Instrument
- Decision date
- 2024-07-24
- Date received
- 2024-04-24
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K241130.pdf
Official FDA record: K241130
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.