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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 K260069
Device Name DePuy Synthes VOLT™ Proximal Tibia 3.5 Plating System
Applicant
Synthes GmbH
Luzernstrasse 21
Zuchwil,  CH 4528
Applicant Contact Enrico Gindro
Correspondent
Synthes GmbH
Luzernstrasse 21
Zuchwil,  CH 4528
Correspondent Contact Enrico Gindro
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Codes
HTD   HWC   HWT  
Date Received01/09/2026
Decision Date 03/09/2026
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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