CARDO MEDICAL CERAMIC HIP SYSTEM

Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented

CARDO MEDICAL, INC

The following data is part of a premarket notification filed by Cardo Medical, Inc with the FDA for Cardo Medical Ceramic Hip System.

Pre-market Notification Details

Device IDK100008
510k NumberK100008
Device Name:CARDO MEDICAL CERAMIC HIP SYSTEM
ClassificationProsthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
Applicant CARDO MEDICAL, INC 10 CLIFTON BLVD SUITE B1 Clifton,  NJ  07011
ContactDave Lamb
CorrespondentDave Lamb
CARDO MEDICAL, INC 10 CLIFTON BLVD SUITE B1 Clifton,  NJ  07011
Product CodeLZO  
CFR Regulation Number888.3353 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-01-04
Decision Date2010-05-18
Summary:summary

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