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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 K251791
Device Name Auxano® Wedge Fixation System
Applicant
Auxano Medical, LLC
8006 Katherine Blvd.
Brecksville,  OH  44141
Applicant Contact Stephen Mezget
Correspondent
Auxano Medical, LLC
8006 Katherine Blvd.
Brecksville,  OH  44141
Correspondent Contact Stephen Mezget
Regulation Number888.3030
Classification Product Code
PLF  
Date Received06/11/2025
Decision Date 09/25/2025
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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