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Which Manufacturers in China Make This?

4 of the 8 manufacturers in China registered for this device type are contract manufacturers, able to build to a buyer’s own specification. They are concentrated in Jiangsu, Shanghai and Zhejiang, and 1 other province.

B-ONE Medical (Suzhou) Co., Ltd. Jiangsu, contract manufacturer
Canwell Medical Co., Ltd. Zhejiang, contract manufacturer
Guangzhou Aquila Precise Tools Limited Guangdong, contract manufacturer
Medtronic (Changzhou) Medical Devices Technology Co., Ltd. Jiangsu
MicroPort Orthopedics Global Supply Center Limited Shanghai, contract manufacturer
Suzhou Microport Orthorecon Co., Ltd. Jiangsu, contract manufacturer
Zhejiang Biomet Medical Products Co., Ltd. Zhejiang, contract manufacturer
Zimmer (Shanghai) Medical International Trading Co., Ltd. Shanghai

How Is KTZ Classified?

Caliper is FDA product code KTZ, Class 1, 21 CFR 888.4150.

How Does It Reach the US Market?

It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States.

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ROD Length Indicator

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