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FDA 510(k)

Spine Navigation and Robotic-Assistance Device

K-Number: K233228 · 2024-06-14

ApplicantEcential Robotics
Decision Date2024-06-14
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Spine Navigation and Robotic-Assistance Device is a medical device manufactured by Ecential Robotics. It received FDA 510(k) clearance on 2024-06-14 under approval number K233228. 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 Spine Navigation and Robotic-Assistance Device?

Spine Navigation and Robotic-Assistance Device is a medical device that received FDA 510(k) clearance on 2024-06-14. It is manufactured by Ecential Robotics. The 510(k) number is K233228.

When was Spine Navigation and Robotic-Assistance Device approved by the FDA?

Spine Navigation and Robotic-Assistance Device received FDA 510(k) clearance on 2024-06-14, under approval number K233228.

What company makes Spine Navigation and Robotic-Assistance Device?

Spine Navigation and Robotic-Assistance Device is manufactured by Ecential Robotics.

What is the FDA product code for Spine Navigation and Robotic-Assistance Device?

The FDA product code for Spine Navigation and Robotic-Assistance Device is OLO.

Related Clinical Trials

NCT06940752 VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters ENROLLING_BY_INVITATION NCT01961557 Evaluating a New Knee-Ankle-Foot Brace to Improve Gait in Children With Movement Disorders COMPLETED NCT07615569 Robot-assisted Versus Conventional Physical Therapy for Hand in Sub-acute Stroke RECRUITING NCT05438719 MOTUS Total Joint Replacement Investigational Device Exemption Study ACTIVE_NOT_RECRUITING NCT07034521 The Feasibility and Therapeutic Effect of Hybrid End-effector Robot-assisted Gait Training With an Active-assisted Module in Chronic Stroke Survivors RECRUITING NCT07593872 XR-Assisted PET/CT Navigation for Cervical Lymph Node Dissection in Lung Cancer NOT_YET_RECRUITING

Related PubMed Literature

PMID: 42201559 Time-series and thematic analyses of clinical utilities and operational issues in early clinical studies of the da Vinci surgical system. Journal of robotic surgery (2026) PMID: 42174947 Aligning AI-Native 6G Healthcare Systems with EU Ethical and Legal Frameworks. Studies in health technology and informatics (2026) PMID: 41839575 A Perspective for Integrating Real-World Evidence Into the Investigational Device Exemption Study Design for Lumbar Total Joint Replacement. International journal of spine surgery (2026) PMID: 41725549 Ethical and legal challenges of integrating artificial intelligence into paediatric surgery. Annals of the Royal College of Surgeons of England (2026)

Other Devices by Ecential Robotics

K221028SURGIVISIO Device K220946SURGIVISIO Device K220627SURGIVISIO Device K231886SURGIVISIO Device K242914Op.n(TM) Navigation

Related Devices (Code: OLO)

K162375Envision 3D: Image Guidance System7D Surgical, Inc. K162341Stryker OrthoMap Precision Knee systemStryker Leibinger GmbH & Co KG K162195TSolution One Cup1 Surgical SystemTHINK Surgical, Inc. K160385Precision ScrewCryptych Pty, Ltd. K153700Aesculap(R) Implant Systems (AIS) S4 Navigation InstrumentsAesculap Implant Systems, LLC K153240Styrker OrthoMap Express Knee SystemStryker Corporate

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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