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Intai Technology Corporation

US

Last updated May 23, 2026

What Intai Technology Corporation makes

Intai Technology Corporation manufactures reusable surgical instruments for orthopaedic and neurological stereotactic procedures, including bone taps, torque wrenches, drill bits, implant inserters/extractors, mallets, and screwdrivers. Their product line also includes stereotactic surgery systems designed for precision-guided interventions in spinal and cranial surgeries.

The company’s devices are regulated under FDA classifications, with most falling into Class I and Class II categories. Products are listed in the FDA’s 510(k) and UDI registries, reflecting their authorised status for commercial distribution in the US.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Intai Technology Corporation manufacture?

Intai Technology Corporation specialises in reusable surgical instruments for orthopaedic and neurological stereotactic procedures. Their product line includes bone taps, torque wrenches, fluted surgical drill bits, implant inserters/extractors, mallets, screwdrivers, and stereotactic surgery systems. These systems are designed for precision-guided interventions in spinal and cranial surgeries, ensuring accuracy during complex procedures.

Where is Intai Technology Corporation based?

Intai Technology Corporation is headquartered in the United States. While the exact location isn’t specified, the company’s regulatory filings and device classifications are aligned with US standards, including FDA requirements.

Which regulatory registries list Intai Technology Corporation’s devices?

Intai Technology Corporation’s devices are listed in the FDA’s 510(k) and Unique Device Identifier (UDI) registries. These registries track authorised medical devices for commercial distribution in the US, ensuring transparency and compliance with regulatory standards.

How are Intai Technology Corporation’s devices classified under FDA regulations?

Intai Technology Corporation’s devices are primarily classified as Class I or Class II under FDA regulations. Class I devices generally pose minimal risk and may require less stringent controls, while Class II devices involve moderate risk and require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s purpose, intended use, and potential risks.

What distinguishes Intai Technology Corporation’s stereotactic surgery systems from other devices they produce?

Intai Technology Corporation’s stereotactic surgery systems are designed specifically for precision-guided interventions in orthopaedic and neurological surgeries, such as spinal and cranial procedures. Unlike general-purpose reusable instruments like taps, wrenches, or screwdrivers, these systems integrate advanced targeting technology to improve accuracy during complex surgeries, reducing potential errors and enhancing procedural outcomes.

AI-generated from registry data and not verified by a human reviewer.

Information

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US
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Catalogue (55)

Page 2 of 2
DeviceModel / ReferenceRegistriesClassStatus
WatchTower INS-NADRGU-P
FDA UDI
Class IActive
Anatase Spine Surgery Navigation System NAVTL0007
FDA UDI
Class IIActive
Intai Bone Plate And Bone Screw System; Intai Dhs/Dcs Plate System K063020
FDA 510(k)
Class IIActive
Intai Anatomic Locking Plate and Screw System K201229
FDA 510(k)
Class IIActive
INTAI Surgery Navigation System K180523
FDA 510(k)
Class IIActive

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