VARI AX DISTAL RADIUS LINE EXTENSIONS OF XXL PLATES

Plate, Fixation, Bone

HOWMEDICA OSTEONICS CORP.

The following data is part of a premarket notification filed by Howmedica Osteonics Corp. with the FDA for Vari Ax Distal Radius Line Extensions Of Xxl Plates.

Pre-market Notification Details

Device IDK100271
510k NumberK100271
Device Name:VARI AX DISTAL RADIUS LINE EXTENSIONS OF XXL PLATES
ClassificationPlate, Fixation, Bone
Applicant HOWMEDICA OSTEONICS CORP. 325 Corporate Drive Mahwah,  NJ  07430
ContactMelissa Matarese
CorrespondentMelissa Matarese
HOWMEDICA OSTEONICS CORP. 325 Corporate Drive Mahwah,  NJ  07430
Product CodeHRS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-01-29
Decision Date2010-05-14
Summary:summary

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