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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
Models 72203841,72203842,7223852,7223853,72203854, 72203842,7223855,72203856, 72209844-45,72203848-49,72203857-59,72203864-66
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 (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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