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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
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