Ion 3D

FDA 510(k) K241416 · SurGenTec, LLC

Substantially Equivalent

510(k) numberK241416

Submission

Device name
Ion 3D
Applicant
SurGenTec, LLC
Boca Raton, FL, US
Received
May 17, 2024
Decision date
June 17, 2024
Decision
Substantially Equivalent (SESE)
Type
Special 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
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

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K262121Ion-L Navigated InstrumentsOLO · Special 07/24/2026SE
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K260329Ion-C Navigation InstrumentsOLO · Traditional 05/22/2026SE
K253604TiLink-L Navigation InstrumentsOLO · Traditional 03/20/2026SE
K251714Ion-CMRW · Traditional 01/16/2026SE
K251720OsteoFlo HydroFiberMQV · Special 07/02/2025SE
K243949OsteoFlo HydroFiberMQV · Traditional 05/28/2025SE
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Questions and answers

When was Ion 3D cleared by the FDA?

Ion 3D (K241416) received a 510(k) decision of Substantially Equivalent on June 17, 2024, 31 days after the submission was received.

What is the product code of K241416?

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