EBI XFIX DFS 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 Ebi Xfix Dfs System.

Pre-market Notification Details

Device IDK013378
510k NumberK013378
Device Name:EBI XFIX DFS SYSTEM
ClassificationAppliance, Fixation, Nail/blade/plate Combination, Multiple Component
Applicant EBI, L.P. 399 JEFFERSON ROAD Parsippany,  NJ  07054
ContactMichael T Taggart
CorrespondentMichael T Taggart
EBI, L.P. 399 JEFFERSON ROAD Parsippany,  NJ  07054
Product CodeKTT  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-10-12
Decision Date2001-11-08
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00887868083631 K013378 000
00887868083587 K013378 000
00887868083570 K013378 000

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