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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 K130196
Device Name SPEEDLOCK KNOTLESS FIXATION DEVICE, 3MM DRILL, 3MM+ DRILL, PATHFINDER OBTURATOR & SHARP TIPPED OBTURATOR, LOW PROFILE DR
Applicant
Arthrocare Corp.
2301 E Saint Elmo Rd. Suite 110
Austin,  TX  78744
Applicant Contact LAURA KASPEROWICZ
Correspondent
Arthrocare Corp.
2301 E Saint Elmo Rd. Suite 110
Austin,  TX  78744
Correspondent Contact LAURA KASPEROWICZ
Regulation Number888.3040
Classification Product Code
MBI  
Date Received01/28/2013
Decision Date 02/27/2013
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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