K252524
- 510(k) number
- K252524
- Device name
- Quadsense (Quadsense and Quadsense Pro)
- Applicant
- Eventum Orthopaedics, Ltd. GB
- Product code
- ONN — Intraoperative Orthopedic Joint Assessment Aid
- Decision date
- 2025-09-09
- Date received
- 2025-08-11
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K252524.pdf
Official FDA record: K252524
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.