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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 K122463
Device Name APERFIX AM FEMORAL IMPLANT WITH INSERTER, 9X24 APERFIX AM FEMORAL IMPLANT WITH INSERTER, 10X24 APERFIX FEMORAL IMPLANT W
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 Received08/13/2012
Decision Date 10/11/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
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