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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name screw, fixation, bone
510(K) Number K122596
Device Name ARTHROSCOPIC SURGICAL INSTRUMENTS - INTERFERENCE SCREW SYSTEMS
Applicant
SMITH & NEPHEW, INC.
150 minuteman rd.
andover,  MA  01810
Contact sean reynolds
Regulation Number888.3040
Classification Product Code
HWC  
Subsequent Product Codes
MAI   MBI  
Date Received08/24/2012
Decision Date 11/20/2012
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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