EBI OPTILOCK UPPER EXTREMITY PLATING SYSTEM

Plate, Fixation, Bone

EBI, L.P.

The following data is part of a premarket notification filed by Ebi, L.p. with the FDA for Ebi Optilock Upper Extremity Plating System.

Pre-market Notification Details

Device IDK062494
510k NumberK062494
Device Name:EBI OPTILOCK UPPER EXTREMITY PLATING SYSTEM
ClassificationPlate, Fixation, Bone
Applicant EBI, L.P. 399 JEFFERSON ROAD Parsippany,  NJ  07054
ContactDebra Bing
CorrespondentDebra Bing
EBI, L.P. 399 JEFFERSON ROAD Parsippany,  NJ  07054
Product CodeHRS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-08-25
Decision Date2006-10-19
Summary:summary

NIH GUDID Devices

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