K252562
- 510(k) number
- K252562
- Device name
- Spine & Trauma Navigation Instruments
- Applicant
- Brainlab AG DE
- Product code
- OLO — Orthopedic Stereotaxic Instrument
- Decision date
- 2025-09-12
- Date received
- 2025-08-14
- 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: K252562.pdf
Official FDA record: K252562
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.