K252841
- 510(k) number
- K252841
- Device name
- REAL INTELLIGENCE CORI XT (CORI XT)
- Applicant
- Blue Belt Technologies, Inc. PA · US
- Product code
- OLO — Orthopedic Stereotaxic Instrument
- Decision date
- 2025-12-05
- Date received
- 2025-09-08
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 1.2 MB · U.S. public domain
Also available from FDA: K252841.pdf
Official FDA record: K252841
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.