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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 K112876
Model CM-9145, CM-9155, CM-9145SP
Device Name CUFFLINK(TM) KNOTLESS ANCHOR WITH INSERTER, 4.5MM/5.5MM - PEEK ONLY, CUFFLINK SP(TM) KNOTLESS ANCHOR WITH INSERTER, 4.5
Original Applicant
CAYENNE MEDICAL, INC.
16597 n. 92nd street
suite 101
scottsdale,  AZ  85260
Original Contact kereshmeh shahriari
Regulation Number888.3040
Classification Product Code
MBI  
Subsequent Product Code
HWC  
Date Received09/30/2011
Decision Date 12/15/2011
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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