K241298
- 510(k) number
- K241298
- Device name
- QUADSENSE
- Applicant
- Eventum Orthopaedics, Ltd. GB
- Product code
- ONN — Intraoperative Orthopedic Joint Assessment Aid
- Decision date
- 2024-10-04
- Date received
- 2024-05-08
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K241298.pdf
Official FDA record: K241298
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.