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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 K083240
Device Name OPUS MAGNUM2 AND OPUS MAGNUM X KNOTLESS FIXATION DEVICES
Applicant
Arthrocare Corp.
15285 Alton Pkwy.
Suite 200
Irvine,  CA  92618
Applicant Contact LAURA N KASPEROWICZ
Correspondent
Arthrocare Corp.
15285 Alton Pkwy.
Suite 200
Irvine,  CA  92618
Correspondent Contact LAURA N KASPEROWICZ
Regulation Number888.3040
Classification Product Code
MBI  
Date Received11/03/2008
Decision Date 01/12/2009
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
Recalls CDRH Recalls
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