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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Staple, Fixation, Bone
510(k) Number K122113
Device Name MEMORY METAL STAPLES, EASYCLIP
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
JDR  
Date Received07/17/2012
Decision Date 03/12/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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