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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 K120943
Device Name SPEEDLOCK HIP KNOTLESS FIXATION IMPLANT SPEEDLOCK HIP DRILL SPEEDLOCK HIP GUIDE CROWN TIP SPEEDLOCK HIP PATHFINDER
Applicant
ARTHROCARE CORPORATION
7000 WEST WILLIAM CANNON DRIVE
BUILDING ONE
AUSTIN,  TX  78735 -0000
Applicant Contact CHERYL FREDRICK
Correspondent
ARTHROCARE CORPORATION
7000 WEST WILLIAM CANNON DRIVE
BUILDING ONE
AUSTIN,  TX  78735 -0000
Correspondent Contact CHERYL FREDRICK
Regulation Number888.3040
Classification Product Code
MBI  
Date Received03/29/2012
Decision Date 09/21/2012
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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