Epic Anterior Thoracolumbar Plate System, Gallery Laminoplasty Fixation System, Concero Facet Screw System, Alpine XC Adjustable Fusion System, Aspen MIS Fusion System, L-Plate MIS Fusion System

Appliance, Fixation, Spinal Intervertebral Body

Zimmer Biomet Spine, Inc.

The following data is part of a premarket notification filed by Zimmer Biomet Spine, Inc. with the FDA for Epic Anterior Thoracolumbar Plate System, Gallery Laminoplasty Fixation System, Concero Facet Screw System, Alpine Xc Adjustable Fusion System, Aspen Mis Fusion System, L-plate Mis Fusion System.

Pre-market Notification Details

Device IDK202309
510k NumberK202309
Device Name:Epic Anterior Thoracolumbar Plate System, Gallery Laminoplasty Fixation System, Concero Facet Screw System, Alpine XC Adjustable Fusion System, Aspen MIS Fusion System, L-Plate MIS Fusion System
ClassificationAppliance, Fixation, Spinal Intervertebral Body
Applicant Zimmer Biomet Spine, Inc. 10225 Westmoor Drive Westminster,  CO  80021
ContactDavid Pollard
CorrespondentDavid Pollard
Zimmer Biomet Spine, Inc. 10225 Westmoor Drive Westminster,  CO  80021
Product CodeKWQ  
Subsequent Product CodeKWP
Subsequent Product CodeMRW
Subsequent Product CodeNQW
CFR Regulation Number888.3060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-08-14
Decision Date2020-10-08

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