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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
Model 3910-600-063
Device Name 3.9MM REELX STT SUTURE ANCHOR SYSTEM
Original Applicant
STRYKER CORP.
3201 e. 3rd ave
denver,  CO  80206
Original Contact kelly kucharczyk
Regulation Number888.3040
Classification Product Code
MBI  
Date Received03/19/2012
Decision Date 07/18/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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