Bit, Surgical
Who Makes This Device Type in China?
3 of the 6 manufacturers in China registered for this device type are contract manufacturers, able to build to a buyer’s own specification. They are concentrated in Guangdong, Shanghai and Jiangsu, and 1 other province.
- Apex (Guangzhou) Tools & Orthopedics Company Guangdong, contract manufacturer
- Guangzhou Aquila Precise Tools Limited Guangdong, contract manufacturer
- Jiangxi Vision Plus Medical Technology Co., Ltd. Jiangxi
- MicroPort Orthopedics Global Supply Center Limited Shanghai, contract manufacturer
- Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai, contract manufacturer
- Suzhou Microport Orthorecon Co., Ltd. Jiangsu, contract manufacturer
How Is GFG Classified?
Bit, Surgical is FDA product code GFG, Class 1, 21 CFR 878.4820.
What Does It Take to Sell It in the United States?
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.
What Has Gone Wrong With It?
The FDA has recorded 17 recalls under this product code since 2005. None was by a company in China. The root causes the FDA records most often are Device Design (14) and Process control (1).
A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.
Repiphysis®
Catalogue number 28701005, listed by Microport Orthopedics Inc., United States, under Bit, Surgical. 6 manufacturers in China are registered for this product code.