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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 K261351
Device Name SALGINA 2.5mm Distal Radius System
Applicant
Bonebridge AG
Bahnhofstrasse 11
Zug,  CH 6300
Applicant Contact Salome Bruetsch
Correspondent
Bonebridge AG
Bahnhofstrasse 11
Zug,  CH 6300
Correspondent Contact Salome Bruetsch
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received04/24/2026
Decision Date 06/26/2026
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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