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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 K073054
Device Name MODIFICATION TO APERFIX FEMORAL IMPLANT WITH INSERTER
Applicant
CAYENNE MEDICAL, INC.
11234 EL CAMINO REAL
SUITE 200
san diego,  CA  92130
Applicant Contact david j collette
Correspondent
CAYENNE MEDICAL, INC.
11234 EL CAMINO REAL
SUITE 200
san diego,  CA  92130
Correspondent Contact david j collette
Regulation Number888.3040
Classification Product Code
HWC  
Date Received10/30/2007
Decision Date 11/27/2007
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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