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FDA 510(k)

Op.n™ Spine Navigation and Robotic Guidance

K-Number: K261113 · 2026-07-22

ApplicantEcential Robotics
Decision Date2026-07-22
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Op.n™ Spine Navigation and Robotic Guidance is the device name listed in this FDA 510(k) record. The listed applicant is Ecential Robotics. It received FDA 510(k) clearance on 2026-07-22 under 510(k) number K261113. 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 Op.n™ Spine Navigation and Robotic Guidance?

Op.n™ Spine Navigation and Robotic Guidance is a medical device that received FDA 510(k) clearance on 2026-07-22. The listed applicant is Ecential Robotics. The 510(k) number is K261113.

When did Op.n™ Spine Navigation and Robotic Guidance receive FDA 510(k) clearance?

Op.n™ Spine Navigation and Robotic Guidance received FDA 510(k) clearance on 2026-07-22, under 510(k) number K261113.

Who is the listed applicant for Op.n™ Spine Navigation and Robotic Guidance?

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

What is the FDA product code for Op.n™ Spine Navigation and Robotic Guidance?

The FDA product code for Op.n™ Spine Navigation and Robotic Guidance is OLO.

Related Clinical Trials

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Other records listing Ecential Robotics 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.

K242914Op.n(TM) NavigationK233228Spine Navigation and Robotic-Assistance DeviceK231886SURGIVISIO DeviceK221028SURGIVISIO DeviceK220946SURGIVISIO DeviceK220627SURGIVISIO Device

View all 7 devices →

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.

K262121Ion-L Navigated InstrumentsSurGenTec, LLCK261024TMINI Miniature Robotic SystemTHINK Surgical, Inc.K261852OTS 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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