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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 K121018
Device Name BIORAPTOR 2.9, BIORAPTOR 2.3 PK, OSTEORAPTOR, & BIORAPTOR KNOTLESS SUTURE AN
Original Applicant
SMITH & NEPHEW, INC.
7135 goodlett farms parkway
cordova,  TN  38016
Original Contact john connor
Regulation Number888.3040
Classification Product Code
MBI  
Subsequent Product Code
MAI  
Date Received04/04/2012
Decision Date 06/22/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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