K260011
- 510(k) number
- K260011
- Device name
- Foundation Surgical Navigated Lateral Disc Prep Instruments
- Applicant
- Foundation Surgical Group, Inc. AZ · US
- Product code
- OLO — Orthopedic Stereotaxic Instrument
- Decision date
- 2026-04-16
- Date received
- 2026-01-02
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K260011.pdf
Official FDA record: K260011
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.