COREN TOTAL HIP SYSTEM

Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented

CORENTEC CO., LTD

The following data is part of a premarket notification filed by Corentec Co., Ltd with the FDA for Coren Total Hip System.

Pre-market Notification Details

Device IDK103431
510k NumberK103431
Device Name:COREN TOTAL HIP SYSTEM
ClassificationProsthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Applicant CORENTEC CO., LTD 11234 EL CAMINO REAL SUITE 200 San Diego,  CA  92130
ContactKevin A Thomas
CorrespondentKevin A Thomas
CORENTEC CO., LTD 11234 EL CAMINO REAL SUITE 200 San Diego,  CA  92130
Product CodeLPH  
CFR Regulation Number888.3358 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-11-23
Decision Date2011-07-21
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08806373830778 K103431 000
08806373830600 K103431 000
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08806373830624 K103431 000
08806373830631 K103431 000
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08806373830655 K103431 000
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08806373830693 K103431 000
08806373830709 K103431 000
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08806373830723 K103431 000
08806373830730 K103431 000
08806373830747 K103431 000
08806373830761 K103431 000
08806373830594 K103431 000

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