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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name fastener, fixation, nondegradable, soft tissue
510(k) Number K120824
Device Name 3.9MM REELX STT SUTURE ANCHOR SYSTEM
Applicant
STRYKER CORP.
3201 E. 3RD AVE
DENVER,  CO  80206
Applicant Contact KELLY KUCHARCZYK
Correspondent
STRYKER CORP.
3201 E. 3RD AVE
DENVER,  CO  80206
Correspondent Contact KELLY KUCHARCZYK
Regulation Number888.3040
Classification Product Code
MBI  
Date Received03/19/2012
Decision Date 07/18/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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