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FDA 510(k)

Ion-L Navigated Instruments

K-Number: K262121 · 2026-07-24

ApplicantSurGenTec, LLC
Decision Date2026-07-24
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Ion-L Navigated Instruments is the device name listed in this FDA 510(k) record. The listed applicant is SurGenTec, LLC. It received FDA 510(k) clearance on 2026-07-24 under 510(k) number K262121. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ion-L Navigated Instruments?

Ion-L Navigated Instruments is a medical device that received FDA 510(k) clearance on 2026-07-24. The listed applicant is SurGenTec, LLC. The 510(k) number is K262121.

When did Ion-L Navigated Instruments receive FDA 510(k) clearance?

Ion-L Navigated Instruments received FDA 510(k) clearance on 2026-07-24, under 510(k) number K262121.

Who is the listed applicant for Ion-L Navigated Instruments?

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-L Navigated Instruments?

The FDA product code for Ion-L Navigated Instruments is OLO.

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.

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Related Devices (Code: OLO)

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.

K261024TMINI Miniature Robotic SystemTHINK Surgical, Inc.K261113Op.n™ Spine Navigation and Robotic GuidanceEcential RoboticsK261852OTS HipOrtoma ABK253921VERTICALE® Navigation InstrumentsSilony Medical GmbHK260480VELYS™ Robotic-Assisted SolutionDepuy Ireland UCK260369Dynamis Robotic Surgical SystemLEM Surgical AG

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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