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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 K110476
Device Name AXSOS (TM) LOCKING PLATE SYSTEM
Applicant
STRYKER CORP.
325 Corporate Drive
Mahwah,  NJ  07430
Applicant Contact ESTELA CELI
Correspondent
STRYKER CORP.
325 Corporate Drive
Mahwah,  NJ  07430
Correspondent Contact ESTELA CELI
Regulation Number888.3030
Classification Product Code
HRS  
Date Received02/18/2011
Decision Date 03/18/2011
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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