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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 K122059
Device Name ALL-SUTURE ANCHOR TWIST DRILL FOR ALL-SUTURE ANCHORS INLINE DRILL GUIDE FOR ALL-SUTURE ANCHORS
Original Applicant
SMITH & NEPHEW, INC.
150 minuteman rd.
andover,  MA  01810
Original Contact karin desjardins
Regulation Number888.3040
Classification Product Code
MBI  
Date Received07/13/2012
Decision Date 03/18/2013
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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