Enztec Reamer 63mm – Crossbar
Catalogue number 4250-7963, listed by Enztec Limited, New Zealand, under Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment. 23 manufacturers in China are registered for this product code.
Instrument, Surgical, Orthopedic, Ac-Powered Motor and Accessory/Attachment
Who Makes This Device Type in China?
11 of the 23 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 Guangdong, and 5 other provinces.
- Apex (Guangzhou) Tools & Orthopedics Company Guangdong, contract manufacturer
- Arthrex (Shanghai) Co., Ltd. Shanghai
- Arthrex Medical Device (Shanghai) Co., Ltd. Shanghai
- Autocam Medical Devices (Suzhou) Co., Ltd. Jiangsu, contract manufacturer
- Canwell Medical Co., Ltd. Zhejiang, contract manufacturer
- Chongqing Orthopaedic Technology Institute Co., Ltd. Chongqing
- Dongguan BAO Kang Dian ZI KE JI Limited Guangdong, contract manufacturer
- Guangzhou Aquila Precise Tools Limited Guangdong, contract manufacturer
- Guizhou Zirui Technology Co., Ltd. Guizhou
- Hing KA Yuen Health Technology (Changzhou )Co., Ltd. Jiangsu
- Jiangsu Baide Medical Instrument Co., Ltd. Jiangsu, contract manufacturer
- Jiangxi Vision Plus Medical Technology Co., Ltd. Jiangxi
- Jabil Circuit (Shanghai) Ltd. Shanghai, contract manufacturer
- Medtronic (Changzhou) Medical Devices Technology Co., Ltd. Jiangsu
- MicroPort Orthopedics Global Supply Center Limited Shanghai, contract manufacturer
- Paragon Medical Device (Changzhou) Co., Ltd. Jiangsu, contract manufacturer
- Shaanxi Ansen Medical Technology Development Co., Ltd. Shaanxi, contract manufacturer
- Shanghai Bojin Medical Instrument Co., Ltd. Shanghai
- Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai, contract manufacturer
- Suzhou Microport Orthorecon Co., Ltd. Jiangsu, contract manufacturer
- Stryker (Suzhou) Medical Technology Co., Ltd. Jiangsu, contract manufacturer
- Suzhou Ahno Medical Devices Co., Ltd. Jiangsu, contract manufacturer
- Zhejiang Biomet Medical Products Co., Ltd. Zhejiang, contract manufacturer
How Is HWE Classified?
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment is FDA product code HWE, Class 1, 21 CFR 878.4820.
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 Has Gone Wrong With It?
The FDA has recorded 101 recalls under this product code since 2003. None was by a company in China. 2 are Class I, the most serious grade.
The root causes the FDA records most often are Process control (63), Labeling False and Misleading (11) and Device Design (7). A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.
Name
Record
Acetabular Reamer D55 Mm HPF
2 catalogue numbers from H0030555599, listed by HPF SRL, under Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment. 23 manufacturers in China are registered for this product code.