VariAx 2 System

Screw, Fixation, Bone

Stryker GmbH

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

Pre-market Notification Details

Device IDK173135
510k NumberK173135
Device Name:VariAx 2 System
ClassificationScrew, Fixation, Bone
Applicant Stryker GmbH 325 Corporate Drive Mahwah,  NJ  07430
ContactPaul Nelson
CorrespondentPaul Nelson
Stryker GmbH 325 Corporate Drive Mahwah,  NJ  07430
Product CodeHWC  
Subsequent Product CodeHRS
Subsequent Product CodeHTN
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-09-29
Decision Date2017-11-27
Summary:summary

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