VariAx Foot

Plate, Fixation, Bone

Stryker GmbH

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

Pre-market Notification Details

Device IDK192675
501k NumberK192675
Device Name:VariAx Foot
ClassificationPlate, Fixation, Bone
Applicant Stryker GmbH 325 Corporate Drive Mahwah,  NJ  07430
ContactJemin Dedania
CorrespondentJemin Dedania
Stryker GmbH 325 Corporate Drive Mahwah,  NJ  07430
Product CodeHRS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyOrthopedic
501k Review PanelOrthopedic
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-09-26
Decision Date2019-11-22

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