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510(k) K192281

Device
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
Applicant
Medos International SARL
510(k) number
K192281
Product code
MRW  
Decision
Substantially Equivalent (SESE)
Decision date
2019-11-20
Date received
2019-08-22
Regulation
510(k) Premarket Notification
Classification name
System, Facet Screw Spinal Device
Medical specialty
510(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
Review panel
Orthopedic
Device class
U
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Sergio M. Cordeiro
Address
Chemin-Blanc 38 Le Locle CH 2400 2400

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MRW  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K253676CORUS™ Posterior Cervical Stabilization System 3D (CORUS™ PCSS 3D)Providence Medical Technology, Inc.2026-05-14
K253432DiversiVy™ Facet Screw SystemVy Spine, LLC2026-03-19
K251714Ion-CSurGenTec, LLC2026-01-16
K250679FFX Facet Fixation SystemSc Medica2025-12-04
K253190CORUS-LX ImplantProvidence Medical Technology, Inc.2025-11-20
K252153FFX Facet Fixation SystemSc Medica2025-10-16
K251885CAVUX Facet Fixation System (CAVUX FFS) and CORUS-LX ImplantProvidence Medical Technology, Inc.2025-07-10
K250920Arthrex Spine Compression FT ScrewArthrex, Inc.2025-05-22
K242527The Karma® Fixation SystemSpinal Elements, Inc.2025-05-21
K243865AERO MIS Facet Fusion SystemAurora Spine2025-03-24
K243265Ion 3DSurGenTec, LLC2024-12-04
K242650zLOCK Lumbar Facet Fixation SystemZygofix , Ltd.2024-09-20
K241035PMT Posterior Cervical Stabilization System (PCSS)Providence Medical Technology, Inc.2024-06-25
K241416Ion 3DSurGenTec, LLC2024-06-17
K232468SC Medica FFXSc Medica2024-05-09

Legacy Summary#

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FDA Review#

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