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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Fixation, Bone
510(k) Number K212581
Device Name VariAx 2 Distal Radius System, VariAx 2 Distal Ulna System
Applicant
Stryker GmbH
325 Corporate Dr.
Mahwah,  NJ  07430
Applicant Contact Keith Neligan
Correspondent
Stryker GmbH
325 Corporate Dr.
Mahwah,  NJ  07430
Correspondent Contact Keith Neligan
Regulation Number888.3030
Classification Product Code
HRS  
Date Received08/16/2021
Decision Date 01/19/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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