Question 1

What types of medical devices does Taiwan Main Orthopaedic Biotechnology Co., Ltd. primarily manufacture?

Accepted Answer

Taiwan Main Orthopaedic Biotechnology Co., Ltd. specializes in surgical planning and navigation-enhancement systems. Their product line includes instrument holders, disposable passive spheres for tracking, minimally invasive spine surgery instruments, navigation hardware like headsets and bone drills, and tracker devices such as the Navi Tracker and Navi Tracker Mobile Stander. These devices are designed to improve precision and efficiency in orthopaedic and spine surgeries.

Question 2

Where is Taiwan Main Orthopaedic Biotechnology Co., Ltd. based?

Accepted Answer

Taiwan Main Orthopaedic Biotechnology Co., Ltd. operates from the United States. While the company name suggests a Taiwanese origin, its primary operational base and regulatory submissions are conducted through its US presence.

Question 3

Which regulatory registries list the devices manufactured by Taiwan Main Orthopaedic Biotechnology Co., Ltd.?

Accepted Answer

The devices produced by Taiwan Main Orthopaedic Biotechnology Co., Ltd. are listed in the FDA’s 510(k) clearance registry and the FDA’s Unique Device Identifier (UDI) system. These registries ensure traceability and compliance with US regulatory requirements for Class II medical devices.

Question 4

How are the devices from Taiwan Main Orthopaedic Biotechnology Co., Ltd. classified under FDA regulations?

Accepted Answer

The devices manufactured by Taiwan Main Orthopaedic Biotechnology Co., Ltd. fall under Class II classification according to FDA regulations. This classification typically applies to devices that pose moderate risk and require special controls to ensure safety and effectiveness, such as surgical navigation systems and minimally invasive instruments.

Device	Model / Reference	Registries	Class	Status
Instrument Holder	MSI-ITH-01	FDA UDI	Class II	Active
Caduceus S	CDS-02	FDA UDI	Class II	Active
Caduceus S	CDS-02	FDA UDI	Class II	Active
Bone Drill	MSI-PDL-01	FDA UDI	Class II	Active
Headset	CDS-SSG-02	FDA UDI	Class II	Active
Navi Tracker	CDS-NTR-02	FDA UDI	Class II	Active
Caduceus S	CDS-02	FDA UDI	Class II	Active
Disposable Passive Sphere	CDS-DPS-00	FDA UDI	Class II	Active
Minimally Invasive Spine Surgery Instruments	MSI-02	FDA UDI	Class II	Active
Connection System	CDS-CNS-02	FDA UDI	Class II	Active
Navi Tracker Mobile Stander	CDS-NGC-04	FDA UDI	Class II	Active
Disposable Passive Sphere	CDS-DPS-04	FDA UDI	Class II	Active
Laptop	CDS-LTP-01	FDA UDI	Class II	Active
Navi Tracker	CDS-NTR-04	FDA UDI	Class II	Active
Router	CDS-RTR-02	FDA UDI	Class II	Active
Navigation Cart	CDS-NGC-03	FDA UDI	Class II	Active
Caduceus S	K242271	FDA 510(k)	Class II	Active
Caduceus S	K220554	FDA 510(k)	Class II	Active

Taiwan Main Orthopaedic Biotechnology Co., Ltd.

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