ENDO HEAD

Prosthesis, Hip, Hemi-, Femoral, Metal Ball

MEDACTA INTERNATIONAL

The following data is part of a premarket notification filed by Medacta International with the FDA for Endo Head.

Pre-market Notification Details

Device IDK111145
510k NumberK111145
Device Name:ENDO HEAD
ClassificationProsthesis, Hip, Hemi-, Femoral, Metal Ball
Applicant MEDACTA INTERNATIONAL 4725 Calle Quetzal, Unit B Camarillo,  CA  93012
ContactAdam Gross
CorrespondentAdam Gross
MEDACTA INTERNATIONAL 4725 Calle Quetzal, Unit B Camarillo,  CA  93012
Product CodeLZY  
CFR Regulation Number888.3360 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-04-22
Decision Date2011-08-16
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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07630030806704 K111145 000

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