VariAx Distal Radius Plating System, VariAx 2 System

Plate, Fixation, Bone

Stryker GmbH

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

Pre-market Notification Details

Device IDK162841
510k NumberK162841
Device Name:VariAx Distal Radius Plating System, VariAx 2 System
ClassificationPlate, Fixation, Bone
Applicant Stryker GmbH 325 Corporate Drive Mahwah,  NJ  07430
ContactIrene Bacalocostantis
CorrespondentIrene Bacalocostantis
Stryker GmbH 325 Corporate Drive Mahwah,  NJ  07430
Product CodeHRS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-10-11
Decision Date2017-02-21
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07613327314625 K162841 000
04546540716040 K162841 000
07613154585113 K162841 000
07613327314496 K162841 000
07613327314502 K162841 000
07613327314519 K162841 000
07613327314526 K162841 000
07613327314533 K162841 000
07613327314540 K162841 000
07613327314557 K162841 000
07613327314571 K162841 000
07613327314588 K162841 000
07613327314595 K162841 000
07613327314601 K162841 000
04546540696953 K162841 000

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