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FDA 510(k)

Ion-C

K-Number: K251714 · 2026-01-16

ApplicantSurGenTec, LLC
Decision Date2026-01-16
Product CodeMRW
DecisionSubstantially Equivalent

Device Summary

Ion-C is the device name listed in this FDA 510(k) record. The listed applicant is SurGenTec, LLC. It received FDA 510(k) clearance on 2026-01-16 under 510(k) number K251714. The device is classified under product code MRW. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ion-C?

Ion-C is a medical device that received FDA 510(k) clearance on 2026-01-16. The listed applicant is SurGenTec, LLC. The 510(k) number is K251714.

When did Ion-C receive FDA 510(k) clearance?

Ion-C received FDA 510(k) clearance on 2026-01-16, under 510(k) number K251714.

Who is the listed applicant for Ion-C?

The FDA 510(k) record lists SurGenTec, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ion-C?

The FDA product code for Ion-C is MRW.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT06720948The ION Facet Screw System Ambispective EvaluationENROLLING_BY_INVITATIONNCT07784673OsteoFlo HydroFiber Ambispective EvaluationENROLLING_BY_INVITATION

Other records listing SurGenTec, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262121Ion-L Navigated InstrumentsK261209Ion-LK260329Ion-C Navigation InstrumentsK253604TiLink-L Navigation InstrumentsK251720OsteoFlo HydroFiberK243949OsteoFlo HydroFiber

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Related Devices (Code: MRW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261209Ion-LSurGenTec, LLCK253676CORUS™ Posterior Cervical Stabilization System 3D (CORUS™ PCSS 3D)Providence Medical Technology, Inc.K253432DiversiVy™ Facet Screw SystemVy Spine, LLCK250679FFX Facet Fixation SystemSc MedicaK253190CORUS-LX ImplantProvidence Medical Technology, Inc.K252153FFX Facet Fixation SystemSc Medica

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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