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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 K151178
Device Name VariAx 2 Wrist Fusion System
Applicant
Stryker Trauma AG
PROF.-KUNTSCHER-STR. 1-5
SCHOENKIRCHEN,  DE 24232
Applicant Contact DR. HEIKE GUSTKE
Correspondent
Stryker Trauma AG
PROF.-KUNTSCHER-STR. 1-5
SCHOENKIRCHEN,  DE 24232
Correspondent Contact DR. HEIKE GUSTKE
Regulation Number888.3030
Classification Product Code
HRS  
Date Received05/04/2015
Decision Date 06/24/2015
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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