AEGIS Anterior Lumbar Plate System, ALC Dynamized Fixation System, Anterior ISOLA Spine System, BOWTI Anterior Buttress Staple Spinal System, DISCOVERY Screw System, EXPEDIUM Anterior Spine System, FRONTIER Anterior Scoliosis System, KANEDA Anterior

System, Facet Screw Spinal Device

Medos International SARL

The following data is part of a premarket notification filed by Medos International Sarl with the FDA for Aegis Anterior Lumbar Plate System, Alc Dynamized Fixation System, Anterior Isola Spine System, Bowti Anterior Buttress Staple Spinal System, Discovery Screw System, Expedium Anterior Spine System, Frontier Anterior Scoliosis System, Kaneda Anterior .

Pre-market Notification Details

Device IDK192281
501k NumberK192281
Device Name:AEGIS Anterior Lumbar Plate System, ALC Dynamized Fixation System, Anterior ISOLA Spine System, BOWTI Anterior Buttress Staple Spinal System, DISCOVERY Screw System, EXPEDIUM Anterior Spine System, FRONTIER Anterior Scoliosis System, KANEDA Anterior
ClassificationSystem, Facet Screw Spinal Device
Applicant Medos International SARL Chemin-Blanc 38 Le Locle,  CH 2400
ContactSergio M. Cordeiro
CorrespondentSergio M. Cordeiro
DePuy Synthes Spine 325 Paramount Drive Raynham,  MA  02767
Product CodeMRW  
Subsequent Product CodeKWQ
Subsequent Product CodeNKB
Subsequent Product CodeNQW
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical Specialty510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices
501k Review PanelOrthopedic
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-08-22
Decision Date2019-11-20

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