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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 K080667
Device Name VARIAX DISTAL RADIUS TORX SCREWS
Applicant
HOWMEDICA OSTEONICS CORP.
325 Corporate Drive
Mahwah,  NJ  07430
Applicant Contact DANIELLE HILLMAN
Correspondent
HOWMEDICA OSTEONICS CORP.
325 Corporate Drive
Mahwah,  NJ  07430
Correspondent Contact DANIELLE HILLMAN
Regulation Number888.3030
Classification Product Code
HRS  
Date Received03/10/2008
Decision Date 03/19/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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