RibFix Blu Thoracic Fixation System

Plate, Fixation, Bone

Biomet Microfixation

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

Pre-market Notification Details

Device IDK212608
510k NumberK212608
Device Name:RibFix Blu Thoracic Fixation System
ClassificationPlate, Fixation, Bone
Applicant Biomet Microfixation 1520 Tradeport Drive Jacksonville,  FL  32218
ContactLauren Jasper
CorrespondentChristine Scifert
MRC Global, LLC 9085 East Mineral Circle, Suite 110 Centennial,  CO  80112
Product CodeHRS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-08-17
Decision Date2022-04-22

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