VARIAX ELBOW SYSTEM PLATE LINE EXTENSION

Plate, Fixation, Bone

HOWMEDICA OSTEONICS CORP.

The following data is part of a premarket notification filed by Howmedica Osteonics Corp. with the FDA for Variax Elbow System Plate Line Extension.

Pre-market Notification Details

Device IDK093433
510k NumberK093433
Device Name:VARIAX ELBOW SYSTEM PLATE LINE EXTENSION
ClassificationPlate, Fixation, Bone
Applicant HOWMEDICA OSTEONICS CORP. 325 Corporate Drive Mahwah,  NJ  07430
ContactMelissa A Matarese
CorrespondentMelissa A Matarese
HOWMEDICA OSTEONICS CORP. 325 Corporate Drive Mahwah,  NJ  07430
Product CodeHRS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-11-04
Decision Date2010-01-28
Summary:summary

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