STRYKER PLATING SYSTEM

Plate, Fixation, Bone

HOWMEDICA OSTEONICS CORP.

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

Pre-market Notification Details

Device IDK060798
510k NumberK060798
Device Name:STRYKER PLATING SYSTEM
ClassificationPlate, Fixation, Bone
Applicant HOWMEDICA OSTEONICS CORP. 325 Corporate Drive Mahwah,  NJ  07430
ContactVivian Kelly
CorrespondentVivian Kelly
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 Received2006-03-24
Decision Date2006-04-12
Summary:summary

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