MODIFICATION TO EBI DYNAFIX DIAPHYSEAL CORRECTION SYSTEM

Appliance, Fixation, Nail/blade/plate Combination, Multiple Component

EBI, L.P.

The following data is part of a premarket notification filed by Ebi, L.p. with the FDA for Modification To Ebi Dynafix Diaphyseal Correction System.

Pre-market Notification Details

Device IDK030372
510k NumberK030372
Device Name:MODIFICATION TO EBI DYNAFIX DIAPHYSEAL CORRECTION SYSTEM
ClassificationAppliance, Fixation, Nail/blade/plate Combination, Multiple Component
Applicant EBI, L.P. 399 JEFFERSON ROAD Parsippany,  NJ  07054
ContactFrederic Testa
CorrespondentFrederic Testa
EBI, L.P. 399 JEFFERSON ROAD Parsippany,  NJ  07054
Product CodeKTT  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-02-04
Decision Date2003-03-06
Summary:summary

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