FACIAL PREBENT PLATING WITH VIRTUAL SURGICAL PLANNING

Plate, Bone

BIOMET MICROFIXATION

The following data is part of a premarket notification filed by Biomet Microfixation with the FDA for Facial Prebent Plating With Virtual Surgical Planning.

Pre-market Notification Details

Device IDK132600
510k NumberK132600
Device Name:FACIAL PREBENT PLATING WITH VIRTUAL SURGICAL PLANNING
ClassificationPlate, Bone
Applicant BIOMET MICROFIXATION 1520 TRADEPORT DR. Jacksonville,  FL  32218
ContactElizabeth Wheeler
CorrespondentElizabeth Wheeler
BIOMET MICROFIXATION 1520 TRADEPORT DR. Jacksonville,  FL  32218
Product CodeJEY  
Subsequent Product CodeDZJ
Subsequent Product CodeLLZ
CFR Regulation Number872.4760 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-08-20
Decision Date2013-10-02
Summary:summary

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