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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Fixation, Bone
510(k) Number K251892
Device Name MAXXOS P.A.C.E. Foot & Ankle Plating System
Applicant
Maxxos Medical GmbH
Kirchbühlstraße 6
Mahlstetten,  DE 78601
Applicant Contact Mark Schenk
Correspondent
Maxxos Medical GmbH
Kirchbühlstraße 6
Mahlstetten,  DE 78601
Correspondent Contact Mark Schenk
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received06/20/2025
Decision Date 09/08/2025
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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