Ion-L

FDA 510(k) K261209 · SurGenTec, LLC

Substantially Equivalent

510(k) numberK261209

Submission

Device name
Ion-L
Applicant
SurGenTec, LLC
Boca Raton, FL, US
Received
April 13, 2026
Decision date
June 11, 2026
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

510(k)DeviceApplicantDecision
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
K243865AERO MIS Facet Fusion SystemMRW · Traditional Aurora Spine03/24/2025SE

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K251714Ion-CMRW · Traditional 01/16/2026SE
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Questions and answers

When was Ion-L cleared by the FDA?

Ion-L (K261209) received a 510(k) decision of Substantially Equivalent on June 11, 2026, 59 days after the submission was received.

What is the product code of K261209?

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