OMEGA 2 SYSTEM

Appliance, Fixation, Nail/blade/plate Combination, Multiple Component

HOWMEDICA OSTEONICS CORP.

The following data is part of a premarket notification filed by Howmedica Osteonics Corp. with the FDA for Omega 2 System.

Pre-market Notification Details

Device IDK041001
510k NumberK041001
Device Name:OMEGA 2 SYSTEM
ClassificationAppliance, Fixation, Nail/blade/plate Combination, Multiple Component
Applicant HOWMEDICA OSTEONICS CORP. 325 Corporate Drive Mahwah,  NJ  07430
ContactVivian Kelly
CorrespondentVivian Kelly
HOWMEDICA OSTEONICS CORP. 325 Corporate Drive Mahwah,  NJ  07430
Product CodeKTT  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-04-19
Decision Date2004-07-01
Summary:summary

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