K251315
- 510(k) number
- K251315
- Device name
- Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II
- Applicant
- Remex Medical Corp. TW
- Product code
- OLO — Orthopedic Stereotaxic Instrument
- Decision date
- 2025-05-29
- Date received
- 2025-04-29
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 3.0 MB · U.S. public domain
Also available from FDA: K251315.pdf
Official FDA record: K251315
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.