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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 K153313
Device Name SpeedLock Knotless Fixation System
Applicant
ArthroCare Corporation
15285 Alton Parway, Suite 200
Irvine,  CA  92618
Applicant Contact LAURA KASPEROWICZ
Correspondent
ArthroCare Corporation
15285 Alton Parway, Suite 200
Irvine,  CA  92618
Correspondent Contact LAURA KASPEROWICZ
Regulation Number888.3040
Classification Product Code
MBI  
Date Received11/17/2015
Decision Date 12/11/2015
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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