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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 K243308
Device Name Bonebridge Osteosynthesis Plating System (SALGINA 2.5mm Distal Radius System, CASCELLA 3.5mm Superior Clavicle System, LEPORELLO 3.5mm Olecranon Syste)
Applicant
Bonebridge AG
Bahnhofstrasse 11
Zug,  CH 6300
Applicant Contact Michelle Gumpelmayer
Correspondent
Bonebridge AG
Bahnhofstrasse 11
Zug,  CH 6300
Correspondent Contact Michelle Gumpelmayer
Regulation Number888.3030
Classification Product Code
HRS  
Date Received10/21/2024
Decision Date 12/20/2024
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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