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510(k) K113011

Device
SPARTAN S3 FACET SYSTEM
Applicant
AMENDIA, INC.
510(k) number
K113011
Product code
MRW  
Decision
Substantially Equivalent (SESE)
Decision date
2011-12-06
Date received
2011-10-11
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
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
RICH JANSEN
Address
13540 Guild Ave. Apple Valley MN US 55124 55124

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#

summary

FDA Review#

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