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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 K140604
Device Name MULTIFIX S KNOTLESS FIXATION SYSTEM
Applicant
ARTHROCARE CORPORATION
7000 West William Cannon Drive
Austin,  TX  78735
Applicant Contact MITCHELL DHORITY
Correspondent
ARTHROCARE CORPORATION
7000 West William Cannon Drive
Austin,  TX  78735
Correspondent Contact MITCHELL DHORITY
Regulation Number888.3040
Classification Product Code
MBI  
Date Received03/10/2014
Decision Date 05/14/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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