K262506
- 510(k) number
- K262506
- Device name
- Remex Spine Surgery Navigation - Universal Instruments
- Applicant
- Remex Medical Corp. TW
- Product code
- OLO — Orthopedic Stereotaxic Instrument
- Decision date
- 2026-08-20
- Date received
- 2026-07-21
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Neurology
510(k) Summary (official FDA PDF): K262506.pdf
Official FDA record: K262506
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.