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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 K123240
Device Name SPEEDLOCK HIP KNOTLESS FIXATION IMPLANT
Applicant
ARTHROCARE CORPORATION
7000 W William Cannon Dr
Austin,  TX  78735
Applicant Contact CHERYL FREDERICK
Correspondent
ARTHROCARE CORPORATION
7000 W William Cannon Dr
Austin,  TX  78735
Correspondent Contact CHERYL FREDERICK
Regulation Number888.3040
Classification Product Code
MBI  
Date Received10/16/2012
Decision Date 02/14/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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