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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Intraoperative Orthopedic Joint Assessment Aid
510(k) Number K252524
Device Name Quadsense (Quadsense and Quadsense Pro)
Applicant
Eventum Orthopaedics, Ltd.
Richmond House, Lawnswood Business Park
Redvers Close
Leeds,  GB LS16 6QY
Applicant Contact John Naybour
Correspondent
Hogan Lovells US LLP
1735 Market St.
Floor 23
Philadelphia,  PA  19103
Correspondent Contact Kelliann Payne
Regulation Number882.4560
Classification Product Code
ONN  
Date Received08/11/2025
Decision Date 09/09/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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