K243560
- 510(k) number
- K243560
- Device name
- Remex Spine Surgery Navigation Instrument
- Applicant
- Remex Medical Corp. TW
- Product code
- OLO — Orthopedic Stereotaxic Instrument
- Decision date
- 2024-12-13
- Date received
- 2024-11-18
- 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: K243560.pdf
Official FDA record: K243560
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.