Awl
Who Makes This Device Type in China?
Chinese manufacturers registered for this device type are concentrated in Jiangsu, Shandong and Shanghai, and 3 other provinces: 13 hold an FDA registration. 4 are contract manufacturers.
- Apex (Guangzhou) Tools & Orthopedics Company Guangdong, contract manufacturer
- Beijing Fule Science & Technology Development Co., Ltd. Beijing
- Bothwin (Beijing) Medical Technology Co., Ltd. Beijing
- Changzhou Geasure Medical Apparatus AND Instruments Co., Ltd. Jiangsu, contract manufacturer
- Medtronic (Changzhou) Medical Devices Technology Co., Ltd. Jiangsu
- MicroPort Orthopedics Global Supply Center Limited Shanghai, contract manufacturer
- Shandong Weigao Orthopaedic Device Co., Ltd. Shandong, contract manufacturer
- Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai, contract manufacturer
- Shanghai Reach Medical Instrument Co., Ltd. Shanghai
- Suzhou Endophix Co., Ltd. Jiangsu
- Xinhua Healthcare Industry Co., Limited Shandong, contract manufacturer
- Xinhua Surgical Instrument Co., Ltd. Shandong
- Zhejiang Biomet Medical Products Co., Ltd. Zhejiang, contract manufacturer
What Is FDA Product Code HWJ?
Awl is FDA product code HWJ, Class 1, 21 CFR 888.4540.
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.
What Do the Recalls Say?
The FDA has recorded 26 recalls under this product code since 2020. None was by a company in China. The root causes the FDA records most often are Device Design (24), Process design (1) and Nonconforming Material/Component (1).
A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.
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