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	T6240150	FDA UDI	Class II	Active
KangLi Locking Plates System	T4071014	FDA UDI	Class II	Active
KangLi Pedicle Screw Spinal System	T5837550	FDA UDI	Class II	Unknown
KangLi Pedicle Screw Spinal System	T5826555	FDA UDI	Class II	Unknown
KangLi Pedicle Screw Spinal System	T6240190	FDA UDI	Class II	Active
KangLi Locking Plates System	T4071009	FDA UDI	Class II	Active
KangLi Pedicle Screw Spinal System	T5836050	FDA UDI	Class II	Unknown
KangLi Pedicle Screw Spinal System	T5827035	FDA UDI	Class II	Unknown
KangLi Pedicle Screw Spinal System	T6240130	FDA UDI	Class II	Active
KangLi Pedicle Screw Spinal System	T5837050	FDA UDI	Class II	Unknown
KangLi Pedicle Screw Spinal System	T6240360	FDA UDI	Class II	Unknown
KangLi Locking Plates System	T4071007	FDA UDI	Class II	Active
KangLi Pedicle Screw Spinal System	T6160040	FDA UDI	Class II	Unknown
KangLi Pedicle Screw Spinal System	T6235545	FDA UDI	Class II	Active
KangLi Pedicle Screw Spinal System	T6160045	FDA UDI	Class II	Unknown
KangLi Pedicle Screw Spinal System	T6236555	FDA UDI	Class II	Active
KangLi Pedicle Screw Spinal System	T5837535	FDA UDI	Class II	Unknown
KangLi Pedicle Screw Spinal System	T5837035	FDA UDI	Class II	Unknown
KangLi Pedicle Screw Spinal System	T6160460	FDA UDI	Class II	Unknown
KangLi Pedicle Screw Spinal System	T6240050	FDA UDI	Class II	Active
KangLi Pedicle Screw Spinal System	T5836525	FDA UDI	Class II	Unknown
KangLi Pedicle Screw Spinal System	T5827040	FDA UDI	Class II	Unknown
KangLi Pedicle Screw Spinal System	T6240240	FDA UDI	Class II	Active
KangLi Pedicle Screw Spinal System	T5815545	FDA UDI	Class II	Unknown
KangLi Pedicle Screw Spinal System	T5817540	FDA UDI	Class II	Unknown
KangLi Pedicle Screw Spinal System	T6215545	FDA UDI	Class II	Active
KangLi Pedicle Screw Spinal System	T5826545	FDA UDI	Class II	Unknown
KangLi Locking Plates System	T4071010	FDA UDI	Class II	Active
KangLi Pedicle Screw Spinal System	T6240045	FDA UDI	Class II	Unknown
KangLi Pedicle Screw Spinal System	T5817545	FDA UDI	Class II	Unknown
KangLi Pedicle Screw Spinal System	T5825545	FDA UDI	Class II	Unknown
KangLi Pedicle Screw Spinal System	T5837045	FDA UDI	Class II	Unknown
KangLi Pedicle Screw Spinal System	T5825540	FDA UDI	Class II	Unknown
KangLi Pedicle Screw Spinal System	T5826040	FDA UDI	Class II	Unknown
KangLi Locking Plates System	T4071016	FDA UDI	Class II	Active
KangLi Pedicle Screw Spinal System	T5837540	FDA UDI	Class II	Unknown
KangLi Pedicle Screw Spinal System	T5827545	FDA UDI	Class II	Unknown
KangLi Pedicle Screw Spinal System	T6160190	FDA UDI	Class II	Unknown
KangLi Pedicle Screw Spinal System	T5836535	FDA UDI	Class II	Unknown
KangLi Pedicle Screw Spinal System	T5826550	FDA UDI	Class II	Unknown
KangLi Pedicle Screw Spinal System	T5827045	FDA UDI	Class II	Unknown
KangLi Pedicle Screw Spinal System	T6290090	FDA UDI	Class II	Unknown
KangLi Pedicle Screw Spinal System	T5826540	FDA UDI	Class II	Unknown
KangLi Pedicle Screw Spinal System	T6240320	FDA UDI	Class II	Active
KangLi Pedicle Screw Spinal System	T6240055	FDA UDI	Class II	Active
KangLi Pedicle Screw Spinal System	T6235555	FDA 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

Suzhou Kangli Orthopaedics Instrument Co., Ltd.

What Suzhou Kangli Orthopaedics Instrument Co., Ltd. makes

Frequently asked questions

Information

Catalogue (77)

Related Companies

Authorised Representatives

Importers

Notified Bodies

Authorities