K240701
- 510(k) number
- K240701
- Device name
- Drill Guide; Drill Bit; Spine & Trauma Navigation
- Applicant
- Brainlab AG DE
- Product code
- OLO — Orthopedic Stereotaxic Instrument
- Decision date
- 2024-05-23
- Date received
- 2024-03-14
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 2.9 MB · U.S. public domain
Also available from FDA: K240701.pdf
Official FDA record: K240701
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.