APERFIX FEMORAL IMPLANT WITH INSERTER

Screw, Fixation, Bone

CAYENNE MEDICAL, INC.

The following data is part of a premarket notification filed by Cayenne Medical, Inc. with the FDA for Aperfix Femoral Implant With Inserter.

Pre-market Notification Details

Device IDK062487
510k NumberK062487
Device Name:APERFIX FEMORAL IMPLANT WITH INSERTER
ClassificationScrew, Fixation, Bone
Applicant CAYENNE MEDICAL, INC. 11234 EL CAMINO REAL SUITE 200 San Diego,  CA  92130
ContactFloyd Larson
CorrespondentFloyd Larson
CAYENNE MEDICAL, INC. 11234 EL CAMINO REAL SUITE 200 San Diego,  CA  92130
Product CodeHWC  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-08-25
Decision Date2006-11-17
Summary:summary

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