Pectus Blu Support Bar System

Plate, Fixation, Bone

Biomet Micofixation

The following data is part of a premarket notification filed by Biomet Micofixation with the FDA for Pectus Blu Support Bar System.

Pre-market Notification Details

Device IDK212841
510k NumberK212841
Device Name:Pectus Blu Support Bar System
ClassificationPlate, Fixation, Bone
Applicant Biomet Micofixation 1520 Tradeport Drive Jacksonville,  FL  32218
ContactMark Wladowski
CorrespondentDanielle Besal
MRC Global, LLC 9085 E Mineral Circle, Suite 110 Centennial,  CO  80112
Product CodeHRS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-09-07
Decision Date2022-01-07

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