K241625
- 510(k) number
- K241625
- Device name
- Anatase Navi Disposable Instrument
- Applicant
- Remex Medical Corp. TW
- Product code
- OLO — Orthopedic Stereotaxic Instrument
- Decision date
- 2024-07-05
- Date received
- 2024-06-06
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 1.6 MB · U.S. public domain
Also available from FDA: K241625.pdf
Official FDA record: K241625
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.