INERTIA PEDICLE SCREW SYSTEM, HONOUR SPACER SYSTEM, FACET FIXX, STRUXXURE ANTERIOR CERVICAL PLATE AND SCREWS

Orthosis, Spondylolisthesis Spinal Fixation

NEXXT SPINE LLC

The following data is part of a premarket notification filed by Nexxt Spine Llc with the FDA for Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx, Struxxure Anterior Cervical Plate And Screws.

Pre-market Notification Details

Device IDK141376
510k NumberK141376
Device Name:INERTIA PEDICLE SCREW SYSTEM, HONOUR SPACER SYSTEM, FACET FIXX, STRUXXURE ANTERIOR CERVICAL PLATE AND SCREWS
ClassificationOrthosis, Spondylolisthesis Spinal Fixation
Applicant NEXXT SPINE LLC PO BOX 566 Chesterland,  OH  44026
ContactKaren E Warden
CorrespondentKaren E Warden
NEXXT SPINE LLC PO BOX 566 Chesterland,  OH  44026
Product CodeMNH  
Subsequent Product CodeKWP
Subsequent Product CodeKWQ
Subsequent Product CodeMAX
Subsequent Product CodeMNI
Subsequent Product CodeMQP
Subsequent Product CodeMRW
Subsequent Product CodeODP
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-05-27
Decision Date2014-06-26
Summary:summary

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