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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screw, Fixation, Bone
510(k) Number K083612
Device Name APERFIX FEMORAL IMPLANT WITH INSERTER, 9,10,11 MM X 35MM AND X 29MM
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
HWC  
Date Received12/05/2008
Decision Date 03/04/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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