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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 K122314
Models CM-9129, CM-9145, CM-9145SP, CM-9155
Device Name QUATRO LINK KNOTLESS ANCHOR WITH INSERTER, 2.9MM-PEEK ONLY
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  
Date Received08/01/2012
Decision Date 10/31/2012
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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