Bonebridge Osteosynthesis Plating System

Plate, Fixation, Bone

Bonebridge AG

The following data is part of a premarket notification filed by Bonebridge Ag with the FDA for Bonebridge Osteosynthesis Plating System.

Pre-market Notification Details

Device IDK213864
510k NumberK213864
Device Name:Bonebridge Osteosynthesis Plating System
ClassificationPlate, Fixation, Bone
Applicant Bonebridge AG Bahnhofstrasse 11 Zug,  CH 6300
ContactChristof Gerber
CorrespondentSandra Soniec
meditec Consulting GmbH Obermoosstrasse 23 Boll,  CH 3067
Product CodeHRS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-12-10
Decision Date2022-09-02

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