Biomet Microfixation RibFix Advantage System

Plate, Fixation, Bone

Biomet Micofixation

The following data is part of a premarket notification filed by Biomet Micofixation with the FDA for Biomet Microfixation Ribfix Advantage System.

Pre-market Notification Details

Device IDK203474
510k NumberK203474
Device Name:Biomet Microfixation RibFix Advantage System
ClassificationPlate, Fixation, Bone
Applicant Biomet Micofixation 1520 Tradeport Drive Jacksonville,  FL  32218
ContactLauren Jasper
CorrespondentLauren Jasper
Biomet Micofixation 1520 Tradeport Drive Jacksonville,  FL  32218
Product CodeHRS  
Subsequent Product CodeHTN
Subsequent Product CodeHWC
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-11-25
Decision Date2021-01-28

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