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FDA 510(k)

Ion 3D

K-Number: K240086 · 2024-02-08

ApplicantSurGenTec, LLC
Decision Date2024-02-08
Product CodeMRW
DecisionSubstantially Equivalent

Device Summary

Ion 3D is the device name listed in this FDA 510(k) record. The listed applicant is SurGenTec, LLC. It received FDA 510(k) clearance on 2024-02-08 under 510(k) number K240086. The device is classified under product code MRW. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ion 3D?

Ion 3D is a medical device that received FDA 510(k) clearance on 2024-02-08. The listed applicant is SurGenTec, LLC. The 510(k) number is K240086.

When did Ion 3D receive FDA 510(k) clearance?

Ion 3D received FDA 510(k) clearance on 2024-02-08, under 510(k) number K240086.

Who is the listed applicant for Ion 3D?

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 3D?

The FDA product code for Ion 3D is MRW.

Related Clinical Trials

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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 InstrumentsK251714Ion-CK251720OsteoFlo 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, LLCK251714Ion-CSurGenTec, LLCK250679FFX Facet Fixation SystemSc MedicaK253190CORUS-LX ImplantProvidence Medical Technology, Inc.

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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