FDA.report

510(k) K243865

Device
AERO MIS Facet Fusion System
Applicant
Aurora Spine
510(k) number
K243865
Product code
MRW
Decision
Substantially Equivalent (SESE)
Decision date
2025-03-24
Date received
2024-12-17
Classification name
System, Facet Screw Spinal Device
Medical specialty
Unknown
Review panel
Unknown
Device class
U
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Laszlo Garamszegi
Address
1930 Palomar Pt. Way Suite 103 Carlsbad CA US 92009 92009

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Other 510(k) Records For Product Code MRW

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
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
K240085zLOCK Lumbar Facet Fixation SystemZygofix , Ltd.2024-04-18