SC Medica FFX

FDA 510(k) K232468 · Sc Medica

Substantially Equivalent

510(k) numberK232468

Submission

Device name
SC Medica FFX
Applicant
Sc Medica
Strasbourg, FR
Received
August 15, 2023
Decision date
May 9, 2024
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MRW – System, Facet Screw Spinal Device
Device class
Unclassified
Implant
Yes

Other 510(k)s with product code MRW

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K261209Ion-LMRW · Traditional SurGenTec, LLC06/11/2026SE
K253676CORUS™ Posterior Cervical Stabilization System 3D (CORUS™ PCSS 3D)MRW · Traditional Providence Medical Technology, Inc.05/14/2026SE
K253432DiversiVy™ Facet Screw SystemMRW · Traditional Vy Spine, LLC03/19/2026SE
K251714Ion-CMRW · Traditional SurGenTec, LLC01/16/2026SE
K250679FFX Facet Fixation SystemMRW · Traditional Sc Medica12/04/2025SE
K253190CORUS-LX ImplantMRW · Traditional Providence Medical Technology, Inc.11/20/2025SE
K252153FFX Facet Fixation SystemMRW · Traditional Sc Medica10/16/2025SE
K251885CAVUX Facet Fixation System (CAVUX FFS) and CORUS-LX ImplantMRW · Special Providence Medical Technology, Inc.07/10/2025SE
K250920Arthrex Spine Compression FT ScrewMRW · Traditional Arthrex, Inc.05/22/2025SE
K242527The Karma® Fixation SystemMRW · Traditional Spinal Elements, Inc.05/21/2025SE

More from Spinal Elements, Inc.

510(k)DeviceDecision
K250679FFX Facet Fixation SystemMRW · Traditional 12/04/2025SE
K252153FFX Facet Fixation SystemMRW · Traditional 10/16/2025SE

Questions and answers

When was SC Medica FFX cleared by the FDA?

SC Medica FFX (K232468) received a 510(k) decision of Substantially Equivalent on May 9, 2024, 268 days after the submission was received.

What is the product code of K232468?

The FDA product code is MRW – System, Facet Screw Spinal Device, a Unclassified device.