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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 K153186
Device Name Adjustable Fixation Device
Applicant
Arthrocare Corp.
15285 Alton Pkwy., # 200
Irvine,  CA  92618
Applicant Contact Katherine Marcaccio
Correspondent
Arthrocare Corp.
15285 Alton Pkwy., # 200
Irvine,  CA  92618
Correspondent Contact Katherine Marcaccio
Regulation Number888.3040
Classification Product Code
MBI  
Date Received11/03/2015
Decision Date 01/28/2016
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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