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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 K203002
Device Name SALGINA 2.5mm Volar Distal Radius System, CASCELLA 3.5mm Superior Clavicle System, TAMlNA 3.5mm Proximal Humerus System, TRIFT 3.5mm 1/3 Tubular System
Applicant
Bonebridge AG
Bahnhofstrasse 11
Zug,  CH 6300
Applicant Contact Christof Gerber
Correspondent
Meditec Consulting GmbH
Obermoosstrasse 23
Boll,  CH 3067
Correspondent Contact Sandra Soniec
Regulation Number888.3030
Classification Product Code
HRS  
Date Received10/01/2020
Decision Date 10/05/2021
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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