CONSTRUX EXTERNAL FIXATION DEVICE

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

EBI, LLC

The following data is part of a premarket notification filed by Ebi, Llc with the FDA for Construx External Fixation Device.

Pre-market Notification Details

Device IDK111376
510k NumberK111376
Device Name:CONSTRUX EXTERNAL FIXATION DEVICE
ClassificationAppliance, Fixation, Nail/blade/plate Combination, Multiple Component
Applicant EBI, LLC 399 Jefferson Rd Parsippany,  NJ  07054
ContactMargaret F Crowe
CorrespondentMargaret F Crowe
EBI, LLC 399 Jefferson Rd Parsippany,  NJ  07054
Product CodeKTT  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-05-16
Decision Date2011-08-03
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00887868099786 K111376 000
00887868099700 K111376 000
00887868099717 K111376 000
00887868099724 K111376 000
00887868099731 K111376 000
00887868099748 K111376 000
00887868099755 K111376 000
00887868099762 K111376 000
00887868099779 K111376 000
00887868099656 K111376 000

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