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 Ebi Dynafix Diaphyseal Correction System.

Pre-market Notification Details

Device IDK021695
510k NumberK021695
Device Name:EBI DYNAFIX DIAPHYSEAL CORRECTION SYSTEM
ClassificationAppliance, Fixation, Nail/blade/plate Combination, Multiple Component
Applicant EBI, L.P. 399 JEFFERSON ROAD Parsippany,  NJ  07054
ContactPatricia M Flood
CorrespondentPatricia M Flood
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 Received2002-05-22
Decision Date2002-06-20
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00880304533776 K021695 000
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00888480190318 K021695 000
00888480190349 K021695 000
00888480190431 K021695 000
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00880304487406 K021695 000
00880304489530 K021695 000
00880304490734 K021695 000
00880304492752 K021695 000
00880304532427 K021695 000
00880304533769 K021695 000
00888480444374 K021695 000

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