Twist Drills

Drills, Burrs, Trephines & Accessories (simple, Powered)

Biomet Microfixation

The following data is part of a premarket notification filed by Biomet Microfixation with the FDA for Twist Drills.

Pre-market Notification Details

Device IDK213208
510k NumberK213208
Device Name:Twist Drills
ClassificationDrills, Burrs, Trephines & Accessories (simple, Powered)
Applicant Biomet Microfixation 1520 Tradeport Drive Jacksonville,  FL  32218
ContactMark Wladkowski
CorrespondentDanielle Besal
MRC Global, LLC 9085 E Mineral Circle, Suite 110 Centennial,  CO  80112
Product CodeHBE  
Subsequent Product CodeDZI
Subsequent Product CodeGFG
Subsequent Product CodeHBG
Subsequent Product CodeHTW
Subsequent Product CodeHTZ
CFR Regulation Number882.4310 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-09-29
Decision Date2021-12-23

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