Driver, Prosthesis

Who Makes This Device Type in China?

6 of the 9 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, Zhejiang and Guangdong, 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
Jiangsu Kersen Medical Instrument Co., Ltd. Jiangsu, 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
Suzhou Microport Orthorecon Co., Ltd. Jiangsu, contract manufacturer
Zhejiang Biomet Medical Products Co., Ltd. Zhejiang, contract manufacturer

What Is FDA Product Code HWR?

Driver, Prosthesis is FDA product code HWR, 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 Has Gone Wrong With It?

The FDA has recorded 6 recalls under this product code since 2007. None was by a company in China. The root causes the FDA records most often are Nonconforming Material/Component (2), Device Design (2) and Component change control (1).

A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.

Driver, Prosthesis

SA Reamer Adapter-Assy

Catalogue number SSI006711, listed by Zimmer, Inc., United States, under Driver, Prosthesis. 9 manufacturers in China are registered for this product code.

Driver, Prosthesis

Pinnacle Gription TF

Pinnacle Gription TF Augment Insert TIP 90 Degrees

Driver, Prosthesis

Nexgen®

Catalogue number 00-5887-056-00, listed by Zimmer Trabecular Metal Technology, Inc., United States, under Driver, Prosthesis. 9 manufacturers in China are registered for this product code.

Driver, Prosthesis

9MM Cannulated Dilator

Catalogue number 907790, listed by Biomet Orthopedics, United States, under Driver, Prosthesis. 9 manufacturers in China are registered for this product code.

Driver, Prosthesis

7MM Cannulated Dilator

Catalogue number 907770, listed by Biomet Orthopedics, United States, under Driver, Prosthesis. 9 manufacturers in China are registered for this product code.

Driver, Prosthesis

Femoral Head Impactor Handle

Catalogue number 31-476948, listed by Biomet UK Ltd., United Kingdom, under Driver, Prosthesis. 9 manufacturers in China are registered for this product code.

Driver, Prosthesis

Head Holder 28 MM

Catalogue number SSI006875, listed by Zimmer, Inc., United States, under Driver, Prosthesis. 9 manufacturers in China are registered for this product code.

Driver, Prosthesis

Femoral Driver

Catalogue number 31-477285, listed by Biomet Orthopedics, United States, under Driver, Prosthesis. 9 manufacturers in China are registered for this product code.

Driver, Prosthesis

CONTOUR-Ribbed 2 – Instruments

Catalogue number 130-600/03, listed by Waldemar Link GmbH & Co. KG, Germany, under Driver, Prosthesis. 9 manufacturers in China are registered for this product code.

Driver, Prosthesis

Eagle

Eagle Plus Micro ACP System Counter Torque Device

Driver, Prosthesis

Endoskeleton® TA

Catalogue number 2106-1013, listed by Medtronic Sofamor Danek, Inc., United States, under Driver, Prosthesis. 9 manufacturers in China are registered for this product code.

Driver, Prosthesis

DynaForce

gSource H8 Retaining Driver

Driver, Prosthesis

Composi TCP Modular TAP

Catalogue number 905278, listed by Biomet Orthopedics, United States, under Driver, Prosthesis. 9 manufacturers in China are registered for this product code.

Driver, Prosthesis

Dual Mobility Sleeve Driver

Catalogue number 112-35-0608, listed by Signature Orthopaedics PTY Limited, Australia, under Driver, Prosthesis. 9 manufacturers in China are registered for this product code.

Driver, Prosthesis

Endoskeleton® TC

Catalogue number 5200-1001, listed by Medtronic Sofamor Danek, Inc., United States, under Driver, Prosthesis. 9 manufacturers in China are registered for this product code.

Driver, Prosthesis

Comprehensive Instrumentation

Catalogue number 405898, listed by Biomet Orthopedics, United States, under Driver, Prosthesis. 9 manufacturers in China are registered for this product code.

Driver, Prosthesis

65MM Bridgeback RMR

Catalogue number SSI006826, listed by Zimmer, Inc., United States, under Driver, Prosthesis. 9 manufacturers in China are registered for this product code.

Driver, Prosthesis

50MM Bridgeback RMR

Catalogue number SSI006811, listed by Zimmer, Inc., United States, under Driver, Prosthesis. 9 manufacturers in China are registered for this product code.

Driver, Prosthesis

BIO-Modular

Catalogue number 406514, listed by Biomet Orthopedics, United States, under Driver, Prosthesis. 9 manufacturers in China are registered for this product code.

Driver, Prosthesis

Cannulated Hex Driver Dilator

Catalogue number 907810, listed by Biomet Orthopedics, United States, under Driver, Prosthesis. 9 manufacturers in China are registered for this product code.

Driver, Prosthesis

T15 Hexalobe Drive

Catalogue number 201.047.15, listed by Jace Medical, LLC, United States, under Driver, Prosthesis. 9 manufacturers in China are registered for this product code.

Driver, Prosthesis

11MM Cannulated Dilator

Catalogue number 907810, listed by Biomet Orthopedics, United States, under Driver, Prosthesis. 9 manufacturers in China are registered for this product code.

Driver, Prosthesis

43MM Bridgeback RMR

Catalogue number SSI006804, listed by Zimmer, Inc., United States, under Driver, Prosthesis. 9 manufacturers in China are registered for this product code.

Driver, Prosthesis

42MM Bridgeback RMR

Catalogue number SSI006803, listed by Zimmer, Inc., United States, under Driver, Prosthesis. 9 manufacturers in China are registered for this product code.

Driver, Prosthesis

Trauma

Catalogue number SSI005011, listed by Biomet Orthopedics, United States, under Driver, Prosthesis. 9 manufacturers in China are registered for this product code.

Driver, Prosthesis

Bowti

Bowti Anterior Buttress Staple Staple Inserter

Driver, Prosthesis

3MM Rattler Driver

Catalogue number 948074, listed by Biomet Orthopedics, United States, under Driver, Prosthesis. 9 manufacturers in China are registered for this product code.

Driver, Prosthesis

71MM Bridgeback RMR

Catalogue number SSI006832, listed by Zimmer, Inc., United States, under Driver, Prosthesis. 9 manufacturers in China are registered for this product code.

Driver, Prosthesis

Bencox DA Instruments Hip System

Offset Cup Impactor_Driver

Driver, Prosthesis

F.a.s.t. PEG Driver

2 catalogue numbers from FPD20, listed by Biomet Orthopedics, United States, under Driver, Prosthesis. 9 manufacturers in China are registered for this product code.

Driver, Prosthesis

Trialtis Spine System

TRIALTIS Spine System Unilateral Inserter

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China

2,581device types they are registered for

340,248device records, each naming its maker

31provinces with a registered manufacturer