Question 1

What types of medical devices does Suzhou Kangli Orthopaedics Instrument Co., Ltd. manufacture?

Accepted Answer

Suzhou Kangli Orthopaedics Instrument Co., Ltd. specializes in spinal fixation hardware, including non-bioabsorbable pedicle screws, spinal fixation rods, and connectors for internal fixation systems. They also produce orthopaedic fixation plates, which are used to stabilize bones during surgical procedures. These devices are primarily designed for orthopaedic applications, particularly in spinal and bone stabilization.

Question 2

Where is Suzhou Kangli Orthopaedics Instrument Co., Ltd. based?

Accepted Answer

The company is based in the United States. While the name includes 'Suzhou,' the operational headquarters and manufacturing presence are located within the US, where its devices are developed and distributed.

Question 3

Which regulatory registries list the devices manufactured by Suzhou Kangli Orthopaedics Instrument Co., Ltd.?

Accepted Answer

The devices produced by Suzhou Kangli Orthopaedics Instrument Co., Ltd. are listed in the FDA’s Unique Device Identifier (UDI) database. This registry is used to track and identify medical devices authorized for use in the United States, ensuring transparency and traceability in the healthcare system.

Question 4

How are the devices manufactured by Suzhou Kangli Orthopaedics Instrument Co., Ltd. classified under FDA regulations?

Accepted Answer

The devices produced by Suzhou Kangli Orthopaedics Instrument Co., Ltd., such as their spinal fixation systems and orthopaedic plates, are classified as Class II under FDA regulations. This classification typically applies to devices that pose moderate risk and require special controls to ensure their safety and effectiveness, beyond general controls.

Device	Model / Reference	Registries	Class	Status
KangLi Pedicle Screw Spinal System	T6235555	FDA UDI	Class II	Active
KangLi Pedicle Screw Spinal System	T6160140	EUDAMEDFDA UDI	Class II	Unknown
KangLi Pedicle Screw Spinal System	T6236035	EUDAMEDFDA UDI	Class II	Active
KangLi Pedicle Screw Spinal System	T6240220	FDA UDI	Class II	Active
KangLi Pedicle Screw Spinal System	T5816050	FDA UDI	Class II	Unknown
KangLi Pedicle Screw Spinal System	T5835525	FDA UDI	Class II	Unknown
KangLi Pedicle Screw Spinal System	T5826035	FDA UDI	Class II	Unknown
KangLi Pedicle Screw Spinal System	T5835545	FDA UDI	Class II	Unknown
KangLi Pedicle Screw Spinal System	T5826050	FDA UDI	Class II	Unknown
KangLi Pedicle Screw Spinal System	T5827050	FDA UDI	Class II	Unknown
KangLi Pedicle Screw Spinal System	T6240380	FDA UDI	Class II	Active
KangLi Pedicle Screw Spinal System	T5837040	FDA UDI	Class II	Unknown
KangLi Pedicle Screw Spinal System	T5837545	FDA UDI	Class II	Unknown
KangLi Pedicle Screw Spinal System	T6235550	FDA UDI	Class II	Active
KangLi Pedicle Screw Spinal System	T5826535	FDA UDI	Class II	Unknown
KangLi Pedicle Screw Spinal System	T6240300	EUDAMEDFDA UDI	Class II	Active
KangLi Locking Plates System	T4071006	FDA UDI	Class II	Active
KangLi Pedicle Screw Spinal System	T6240280	FDA UDI	Class II	Active
KangLi Pedicle Screw Spinal System	T6160055	FDA UDI	Class II	Unknown
KangLi Pedicle Screw Spinal System	T6240070	FDA UDI	Class II	Active
KangLi Pedicle Screw Spinal System	T5816550	EUDAMEDFDA UDI	Class II	Unknown
KangLi Pedicle Screw Spinal System	T5825535	FDA UDI	Class II	Unknown
KangLi Pedicle Screw Spinal System	T6240460	FDA UDI	Class II	Active
KangLi Pedicle Screw Spinal System	T6236050	FDA UDI	Class II	Active
KangLi Locking Plates System	T4071008	FDA UDI	Class II	Active
KangLi Pedicle Screw Spinal System	T6160050	EUDAMEDFDA UDI	Class II	Unknown
KangLi Pedicle Screw Spinal System	T6240260	FDA UDI	Class II	Active
KangLi Pedicle Screw Spinal System	T6240170	FDA UDI	Class II	Active
KangLi Pedicle Screw Spinal System	T6290070	FDA UDI	Class II	Active
KangLi Pedicle Screw Spinal System	T5815550	FDA UDI	Class II	Unknown
KangLi Pedicle Screw Spinal System	T5817535	FDA UDI	Class II	Unknown
KangLi Pedicle Screw Spinal System	T5835540	FDA UDI	Class II	Unknown
KangLi Pedicle Screw Spinal System	T5836025	FDA UDI	Class II	Unknown
KangLi Locking Plates System	T4071012	FDA UDI	Class II	Active
KangLi Pedicle Screw Spinal System	T5826045	FDA UDI	Class II	Active
KangLi Pedicle Screw Spinal System	T6240340	FDA UDI	Class II	Active

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