SPECTRUM SPINE FENESTRATED FACET SCREW SYSTEM

System, Facet Screw Spinal Device

SPECTRUM SPINE, LLC

The following data is part of a premarket notification filed by Spectrum Spine, Llc with the FDA for Spectrum Spine Fenestrated Facet Screw System.

Pre-market Notification Details

Device IDK132126
510k NumberK132126
Device Name:SPECTRUM SPINE FENESTRATED FACET SCREW SYSTEM
ClassificationSystem, Facet Screw Spinal Device
Applicant SPECTRUM SPINE, LLC 100 E. SOUTH MAIN ST. P.O. BOX 1458 Waxhaw,  NC  28173
ContactOttie Pendleton
CorrespondentOttie Pendleton
SPECTRUM SPINE, LLC 100 E. SOUTH MAIN ST. P.O. BOX 1458 Waxhaw,  NC  28173
Product CodeMRW  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-07-10
Decision Date2013-10-28
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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00842166180697 K132126 000
00842166192263 K132126 000

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