K250520
- 510(k) number
- K250520
- Device name
- OsteoCentric Navigated Instruments System
- Applicant
- Osteocentric Technologies, Inc. UT · US
- Product code
- OLO — Orthopedic Stereotaxic Instrument
- Decision date
- 2025-10-27
- Date received
- 2025-02-21
- 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: K250520.pdf
Official FDA record: K250520
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.