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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bone Wedge
510(k) Number K252254
Device Name Osteotomy Wedge System
Applicant
Sinaptic Surgical
1885 W. 2100 S.
Slat Lake City,  UT  84119
Applicant Contact Brian Hockett
Correspondent
Sinaptic Surgical
1885 W. 2100 S.
Slat Lake City,  UT  84119
Correspondent Contact Brian Hockett
Regulation Number888.3030
Classification Product Code
PLF  
Date Received07/21/2025
Decision Date 10/17/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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