INTEGRA FACET FIXATION SYSTEM

System, Facet Screw Spinal Device

SEASPINE, INC.

The following data is part of a premarket notification filed by Seaspine, Inc. with the FDA for Integra Facet Fixation System.

Pre-market Notification Details

Device IDK132859
510k NumberK132859
Device Name:INTEGRA FACET FIXATION SYSTEM
ClassificationSystem, Facet Screw Spinal Device
Applicant SEASPINE, INC. 2302 LA MIRADA DR. Vista,  CA  92081 -7862
ContactMichelle Willis
CorrespondentMichelle Willis
SEASPINE, INC. 2302 LA MIRADA DR. Vista,  CA  92081 -7862
Product CodeMRW  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-09-12
Decision Date2013-11-18

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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10889981076467 K132859 000

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