Bender

Who Makes This Device Type in China?

Chinese manufacturers registered for this device type are concentrated in Shanghai, Jiangsu and Beijing, and 3 other provinces: 10 hold an FDA registration. 2 are contract manufacturers.

Apex (Guangzhou) Tools & Orthopedics Company Guangdong, contract manufacturer
Beijing Fule Science & Technology Development 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
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai, contract manufacturer
Shanghai Reach Medical Instrument Co., Ltd. Shanghai
Xinhua Healthcare Industry Co., Limited Shandong, contract manufacturer
Zhejiang Biomet Medical Products Co., Ltd. Zhejiang, contract manufacturer
Zimmer (Shanghai) Medical International Trading Co., Ltd. Shanghai

How Is HXW Classified?

Bender is FDA product code HXW, 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 3 recalls under this product code since 2014. None was by a company in China. The root causes the FDA records most often are Device Design (2) and Finished device change control (1).

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

Charlotte

Catalogue number 41112022, listed by Wright Medical Technology, Inc., United States, under Bender. 10 manufacturers in China are registered for this product code.

Lancer™/Thunderbolt™ Pedicle Screw System

Univ,rod BENDER,5.5

Acura Stabilization System

Catalogue number F004.0083, listed by Bioalign Inc., under Bender. 10 manufacturers in China are registered for this product code.

Gsource

Gratloch Wire Bender 7 1/2", max cap 1.6mm [.062"]

Global Spinal Fixation System™

Catalogue number SGS1004, listed by CG MedTech Co., Ltd., South Korea, under Bender. 10 manufacturers in China are registered for this product code.

Procotyl®

Catalogue number APA05111, listed by Microport Orthopedics Inc., United States, under Bender. 10 manufacturers in China are registered for this product code.

CorticaLINK

French Bender

SpineTune TL

Catalogue number ST9004R, listed by Ldr Spine USA, United States, under Bender. 10 manufacturers in China are registered for this product code.

Ocata Anterior Cervical System

Plate Bender Assembly

Optima™ Spinal System

Catalogue number SG0011, listed by CG MedTech Co., Ltd., South Korea, under Bender. 10 manufacturers in China are registered for this product code.

Nail Bender

Catalogue number 430031T, listed by Biomet Orthopedics, United States, under Bender. 10 manufacturers in China are registered for this product code.

Isola

Isola Spine System ROD Bender (French)

Insignia

Catalogue number 237-0017, listed by Alphatec Spine, Inc., United States, under Bender. 10 manufacturers in China are registered for this product code.

Falcon™ Anterior Cervical Plate

Falcon,plate Bender

Firebird Sfs;icon Sfs;proview;sfs

Catalogue number 55-1042, listed by Orthofix US LLC, United States, under Bender. 10 manufacturers in China are registered for this product code.

Bender

3 points Plate Bender

Pediflex

Mini F-Tool, Handle / Bender

Maxima™ ACP System

Catalogue number SC7010, listed by CG MedTech Co., Ltd., South Korea, under Bender. 10 manufacturers in China are registered for this product code.

Extreme Angle Bender

Catalogue number 14-401418, listed by Biomet Orthopedics, United States, under Bender. 10 manufacturers in China are registered for this product code.

Summit

Summit SI OCT Spinal Fixation System ROD Benders (Tubular) SET

Tangis

Instrument, Plate Bender, Anterior Cervical Plating System (ACP)

Locking Cage

Flange bender

NewPort

Catalogue number 91-2905, listed by Seaspine Orthopedics Corporation, United States, under Bender. 10 manufacturers in China are registered for this product code.

Clearfix Rigid Sternal Fixation Surgical Instrument

Catalogue number CF-26.0240.17, listed by Jeil Medical Corporation, South Korea, under Bender. 10 manufacturers in China are registered for this product code.

Aranax Anterior Cervical Plating System

Catalogue number T086-1100, listed by Xtant Medical Holdings, Inc., United States, under Bender. 10 manufacturers in China are registered for this product code.

Uni-CP Compression Plate

Plate bender 3.5mm

Smart Correction

Ø5.5 Rod Bender, French

Plate Benders (M) (2 Pieces)

Catalogue number FIM 234, listed by Flower Orthopedics Corporation, United States, under Bender. 10 manufacturers in China are registered for this product code.

Virage® OCT

Catalogue number 07.01770.001, listed by Zimmer Biomet Pty Ltd, Australia, under Bender. 10 manufacturers in China are registered for this product code.

Int-Fix

Evos 2.7 AND 3.5MM Bending ROD

Plate Bender

Catalogue number F003.0003, listed by Indius Medical Technologies PVT. Ltd., India, under Bender. 10 manufacturers in China are registered for this product code.

EPS Plating System

Plate Bender (2) Pack 1.5mm

Titan Modular Shoulder System 2.5

Body Separator

Bender

Catalogue number 96-300-76-07, listed by KLS-Martin L.P., United States, under Bender. 10 manufacturers in China are registered for this product code.

Neuro Plating System

Catalogue number IOC-070, listed by Osteonic Co., Ltd., South Korea, under Bender. 10 manufacturers in China are registered for this product code.

General Instrument

Tubular Rod Bender

1.0MM System

Catalogue number 01-7460, listed by Biomet Microfixation, United States, under Bender. 10 manufacturers in China are registered for this product code.

Bowti

Bowti Anterior Buttress Staple Staple Benders

MatrixRIB

Combination Bending Pliers FOR Matrixrib

TraumaOne System

2 catalogue numbers from 46-0001, listed by Biomet Microfixation, United States, under Bender. 10 manufacturers in China are registered for this product code.

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