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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 K081497
Device Name OPUS MAGNUM2 KNOTLESS FIXATION DEVICE (MODEL OM-1502), OPUS MAGNUM X KNOTLESS FIXATION DEVICE (MODEL OM-1503)
Applicant
Arthrocare Corp.
15285 Alton Pkwy., # 200
Irvine,  CA  92618
Applicant Contact LAURA N KASPEROWICZ
Correspondent
Arthrocare Corp.
15285 Alton Pkwy., # 200
Irvine,  CA  92618
Correspondent Contact LAURA N KASPEROWICZ
Regulation Number888.3040
Classification Product Code
MBI  
Date Received05/29/2008
Decision Date 07/28/2008
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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