VARIAX 2 SYSTEM

Plate, Fixation, Bone

Stryker Trauma AG

The following data is part of a premarket notification filed by Stryker Trauma Ag with the FDA for Variax 2 System.

Pre-market Notification Details

Device IDK141992
510k NumberK141992
Device Name:VARIAX 2 SYSTEM
ClassificationPlate, Fixation, Bone
Applicant Stryker Trauma AG 325 Corporate Drive Mahwah,  NJ  07430
ContactEstela Celi
CorrespondentEstela Celi
Stryker Trauma AG 325 Corporate Drive Mahwah,  NJ  07430
Product CodeHRS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-07-22
Decision Date2014-08-07
Summary:summary

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