EBI VUELOCK ANTERIOR CERVICAL PLATE SYSTEM

Appliance, Fixation, Spinal Intervertebral Body

EBI, L.P.

The following data is part of a premarket notification filed by Ebi, L.p. with the FDA for Ebi Vuelock Anterior Cervical Plate System.

Pre-market Notification Details

Device IDK010003
510k NumberK010003
Device Name:EBI VUELOCK ANTERIOR CERVICAL PLATE SYSTEM
ClassificationAppliance, Fixation, Spinal Intervertebral Body
Applicant EBI, L.P. 399 JEFFERSON ROAD Parsippany,  NJ  07054
ContactJon Caparotta
CorrespondentJon Caparotta
EBI, L.P. 399 JEFFERSON ROAD Parsippany,  NJ  07054
Product CodeKWQ  
CFR Regulation Number888.3060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-01-02
Decision Date2001-01-31

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.