APERFIX FEMORAL IMPLANT WITH INSERTER, 9,10,11 MM X 35MM AND X 29MM

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, 9,10,11 Mm X 35mm And X 29mm.

Pre-market Notification Details

Device IDK083612
510k NumberK083612
Device Name:APERFIX FEMORAL IMPLANT WITH INSERTER, 9,10,11 MM X 35MM AND X 29MM
ClassificationScrew, Fixation, Bone
Applicant CAYENNE MEDICAL, INC. 16597 N. 92ND STREET SUITE 101 Scottsdale,  AZ  85260
ContactKereshmeh Shahriari
CorrespondentKereshmeh Shahriari
CAYENNE MEDICAL, INC. 16597 N. 92ND STREET SUITE 101 Scottsdale,  AZ  85260
Product CodeHWC  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-12-05
Decision Date2009-03-04
Summary:summary

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