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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 K063070
Device Name APERFIX TIBIAL IMPLANT WITH INSERTER
Applicant
CAYENNE MEDICAL, INC.
11234 EL CAMINO REAL
SUITE 200
SAN DIEGO,  CA  92130
Applicant Contact Floyd Larson
Correspondent
CAYENNE MEDICAL, INC.
11234 EL CAMINO REAL
SUITE 200
SAN DIEGO,  CA  92130
Correspondent Contact Floyd Larson
Regulation Number888.3040
Classification Product Code
HWC  
Date Received10/06/2006
Decision Date 12/14/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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