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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
Applicant
SMITH & NEPHEW, INC.
150 MINUTEMAN RD.
ANDOVER,  MA  01810
Applicant Contact KARIN DESJARDINS
Correspondent
SMITH & NEPHEW, INC.
150 MINUTEMAN RD.
ANDOVER,  MA  01810
Correspondent 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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