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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 K090615
Device Name OPUS SPEEDLOCK KNOTLESS FIXATION DEVICE
Applicant
ARTHROCARE CORP.
680 VAQUEROS AVE.
SUNNYVALE,  CA  94085 -3523
Applicant Contact LAURA N KASPEROWICZ
Correspondent
ARTHROCARE CORP.
680 VAQUEROS AVE.
SUNNYVALE,  CA  94085 -3523
Correspondent Contact LAURA N KASPEROWICZ
Regulation Number888.3040
Classification Product Code
MBI  
Date Received03/09/2009
Decision Date 06/03/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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