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FDA 510(k)

Fusion Robotic Navigation System

K-Number: K232413 · 2023-09-08

ApplicantAlphatec Spine, Inc.
Decision Date2023-09-08
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Fusion Robotic Navigation System is a medical device manufactured by Alphatec Spine, Inc.. It received FDA 510(k) clearance on 2023-09-08 under approval number K232413. 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 Fusion Robotic Navigation System?

Fusion Robotic Navigation System is a medical device that received FDA 510(k) clearance on 2023-09-08. It is manufactured by Alphatec Spine, Inc.. The 510(k) number is K232413.

When was Fusion Robotic Navigation System approved by the FDA?

Fusion Robotic Navigation System received FDA 510(k) clearance on 2023-09-08, under approval number K232413.

What company makes Fusion Robotic Navigation System?

Fusion Robotic Navigation System is manufactured by Alphatec Spine, Inc..

What is the FDA product code for Fusion Robotic Navigation System?

The FDA product code for Fusion Robotic Navigation System is OLO.

Related Clinical Trials

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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: 41160299 Toward safe clinical deployment of remote robotic surgery in Japan: five-year validation of the hinotori™ system using 5G wireless communication. International journal of clinical oncology (2025) PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025)

Other Devices by Alphatec Spine, Inc.

K160646XYcor® Expandable Spinal Spacer System K161363Arsenal Spinal Fixation System K153603Alphatec Navigation Instruments K173522Solanas® Posterior Stabilization System K182746ATEC ALIF and LLIF Spacer System K182808Aspida® Anterior Lumbar Plating System

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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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