ENDURAMESH, MODEL 762.XXX

Spinal Vertebral Body Replacement Device

LUCERO MEDICAL, LLC

The following data is part of a premarket notification filed by Lucero Medical, Llc with the FDA for Enduramesh, Model 762.xxx.

Pre-market Notification Details

Device IDK093207
510k NumberK093207
Device Name:ENDURAMESH, MODEL 762.XXX
ClassificationSpinal Vertebral Body Replacement Device
Applicant LUCERO MEDICAL, LLC PO BOX 67 Richfield,  OH  44286
ContactJennifer Palinchik
CorrespondentJennifer Palinchik
LUCERO MEDICAL, LLC PO BOX 67 Richfield,  OH  44286
Product CodeMQP  
CFR Regulation Number888.3060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-10-13
Decision Date2010-04-26
Summary:summary

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