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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
Applicant
Cayenne Medical, Inc.
16597 N. 92nd St., Suite 101
Scottsdale,  AZ  85260
Applicant Contact KERESHMEH SHAHRIARI
Correspondent
Cayenne Medical, Inc.
16597 N. 92nd St., Suite 101
Scottsdale,  AZ  85260
Correspondent 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
Predetermined Change
Control Plan Authorized		 No
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