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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 K113760
Device Name VARIAX SUPERIOR AND ANTERIOR, LATERAL AND MIDSHAFT CLAVICLE PLATES VARIAX AIMING BLOCKS & JOYSTICK
Applicant
Howmedica Osteonics Corp., Dba Stryker Orthopaedics
325 Corporate Dr.
Mahwah,  NJ  07430
Applicant Contact VALERIE GIAMBANCO
Correspondent
Howmedica Osteonics Corp., Dba Stryker Orthopaedics
325 Corporate Dr.
Mahwah,  NJ  07430
Correspondent Contact VALERIE GIAMBANCO
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received12/21/2011
Decision Date 04/25/2012
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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