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FDA 510(k)

INTAI Surgery Navigation System

K-Number: K180523 · 2019-09-20

ApplicantIntai Technology Corporation
Decision Date2019-09-20
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

INTAI Surgery Navigation System is a medical device manufactured by Intai Technology Corporation. It received FDA 510(k) clearance on 2019-09-20 under approval number K180523. 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 INTAI Surgery Navigation System?

INTAI Surgery Navigation System is a medical device that received FDA 510(k) clearance on 2019-09-20. It is manufactured by Intai Technology Corporation. The 510(k) number is K180523.

When was INTAI Surgery Navigation System approved by the FDA?

INTAI Surgery Navigation System received FDA 510(k) clearance on 2019-09-20, under approval number K180523.

What company makes INTAI Surgery Navigation System?

INTAI Surgery Navigation System is manufactured by Intai Technology Corporation.

What is the FDA product code for INTAI Surgery Navigation System?

The FDA product code for INTAI Surgery Navigation System is OLO.

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Related PubMed Literature

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: 40866856 Prognostic value of nutritional risk assessment indices in patients with digestive system tumors. BMC cancer (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 Intai Technology Corporation

K201229Intai Anatomic Locking Plate and Screw System

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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