510(k) K252524
K252524 is an FDA 510(k) premarket notification submitted by Eventum Orthopaedics, Ltd. for the device "Quadsense (Quadsense and Quadsense Pro)". The FDA issued a decision of Substantially Equivalent on September 9, 2025. The device falls under product code ONN (Intraoperative Orthopedic Joint Assessment Aid), a Class II device regulated under 21 CFR 882.4560. Eventum Orthopaedics, Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 9, 2025
- Date Received
- August 11, 2025
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Intraoperative Orthopedic Joint Assessment Aid
- Device Class
- Class II
- Regulation Number
- 882.4560
- Review Panel
- OR
- Submission Type
Measurement and interpretation of orthopedic joint information.