EBI TROCHANTERIC NAIL SYSTEM

Rod, Fixation, Intramedullary And Accessories

EBI, L.P.

The following data is part of a premarket notification filed by Ebi, L.p. with the FDA for Ebi Trochanteric Nail System.

Pre-market Notification Details

Device IDK050118
510k NumberK050118
Device Name:EBI TROCHANTERIC NAIL SYSTEM
ClassificationRod, Fixation, Intramedullary And Accessories
Applicant EBI, L.P. 399 JEFFERSON ROAD Parsippany,  NJ  07054
ContactFrederic Testa
CorrespondentFrederic Testa
EBI, L.P. 399 JEFFERSON ROAD Parsippany,  NJ  07054
Product CodeHSB  
CFR Regulation Number888.3020 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-01-18
Decision Date2005-02-16
Summary:summary

NIH GUDID Devices

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