Stryker VariAx 2 MIS Calcaneus

Plate, Fixation, Bone

Stryker GmbH

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

Pre-market Notification Details

Device IDK221346
510k NumberK221346
Device Name:Stryker VariAx 2 MIS Calcaneus
ClassificationPlate, Fixation, Bone
Applicant Stryker GmbH 325 Corporate Drive Mahwah,  NJ  07430
ContactJonathan Schell
CorrespondentJonathan Schell
Stryker GmbH 325 Corporate Drive Mahwah,  NJ  07430
Product CodeHRS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-05-09
Decision Date2022-07-08

© 2022 FDA.report
This site is not affiliated with or endorsed by the FDA.