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510(k) K252524

Quadsense (Quadsense and Quadsense Pro) by Eventum Orthopaedics, Ltd. — Product Code ONN

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.

Other clearances by Eventum Orthopaedics, Ltd.

  • K241298 — QUADSENSE (October 4, 2024)

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