K260601
- 510(k) number
- K260601
- Device name
- REAL INTELLIGENCE CORI
- Applicant
- Blue Belt Technologies, Inc. PA · US
- Product code
- OLO — Orthopedic Stereotaxic Instrument
- Decision date
- 2026-03-26
- Date received
- 2026-02-24
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 3.2 MB · U.S. public domain
Also available from FDA: K260601.pdf
Official FDA record: K260601
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.