EBI P148 SPINAL FIXATION SYSTEM

Orthosis, Spondylolisthesis Spinal Fixation

EBI, L.P.

The following data is part of a premarket notification filed by Ebi, L.p. with the FDA for Ebi P148 Spinal Fixation System.

Pre-market Notification Details

Device IDK031423
510k NumberK031423
Device Name:EBI P148 SPINAL FIXATION SYSTEM
ClassificationOrthosis, Spondylolisthesis Spinal Fixation
Applicant EBI, L.P. 399 JEFFERSON ROAD Parsippany,  NJ  07054
ContactJon Caparetta
CorrespondentJon Caparetta
EBI, L.P. 399 JEFFERSON ROAD Parsippany,  NJ  07054
Product CodeMNH  
Subsequent Product CodeKWP
Subsequent Product CodeKWQ
Subsequent Product CodeMNI
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-05-06
Decision Date2003-06-27
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00880304225497 K031423 000

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