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FDA 510(k)

Ion 3D

K-Number: K243265 · 2024-12-04

ApplicantSurGenTec, LLC
Decision Date2024-12-04
Product CodeMRW
DecisionSubstantially Equivalent

Device Summary

Ion 3D is a medical device manufactured by SurGenTec, LLC. It received FDA 510(k) clearance on 2024-12-04 under approval number K243265. 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 2024-12-04. It is manufactured by SurGenTec, LLC. The 510(k) number is K243265.

When was Ion 3D approved by the FDA?

Ion 3D received FDA 510(k) clearance on 2024-12-04, under approval number K243265.

What company makes Ion 3D?

Ion 3D is manufactured by SurGenTec, LLC.

What is the FDA product code for Ion 3D?

The FDA product code for Ion 3D is MRW.

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Related Devices (Code: MRW)

K161798FacetBRIDGE® SystemLdr Spine USA, Inc. K152137FacetBRIDGE SystemLdr Spine USA K163374ALLY™ Facet ScrewsProvidence Medical Technology, Inc. K180729FaSet Fixation SystemHuvexel Co. , Ltd. K173198Facet Screw Fixation SystemU&I Corporation K192744CORRIDOR Fixation SystemGlobus Medical, 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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