Extractor

Who Makes This Device Type in China?

10 of the 15 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, Guangdong and Shanghai, and 2 other provinces.

Apex (Guangzhou) Tools & Orthopedics Company Guangdong, contract manufacturer
Autocam Medical Devices (Suzhou) Co., Ltd. Jiangsu, contract manufacturer
B-ONE Medical (Suzhou) Co., Ltd. Jiangsu, contract manufacturer
Canwell Medical Co., Ltd. Zhejiang, contract manufacturer
Changzhou Geasure Medical Apparatus AND Instruments Co., Ltd. Jiangsu, contract manufacturer
Guangzhou Aquila Precise Tools Limited Guangdong, contract manufacturer
Medtronic (Changzhou) Medical Devices Technology Co., Ltd. Jiangsu
MicroPort Orthopedics Global Supply Center Limited Shanghai, contract manufacturer
Saferlife Products Co., Ltd. Guangdong, contract manufacturer
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai, contract manufacturer
Suzhou Microport Orthorecon Co., Ltd. Jiangsu, contract manufacturer
Stryker Orthmed (Changzhou) Medical Instrument Co., Ltd. Jiangsu, contract manufacturer
Turnxon Precision Co., Ltd. Guangdong, contract manufacturer
Xinhua Healthcare Industry Co., Limited Shandong, contract manufacturer
Zhejiang Biomet Medical Products Co., Ltd. Zhejiang, contract manufacturer

What Is FDA Product Code HWB?

Extractor is FDA product code HWB, Class 1, 21 CFR 888.4540.

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 Do the Recalls Say?

The FDA has recorded 4 recalls under this product code since 2010. None was by a company in China. The root causes the FDA records most often are Labeling Change Control (1) and Device Design (1).

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

Vital MIS Spinal Fixation System

Easy Out

Virage OCT Spinal Fixation System

Polyaxial Screw Remover

Duraloc

Duraloc Poly Extractor

U2 Hip Stem

Catalogue number 9104-1204, listed by United Orthopedic Corp., Taiwan, under Extractor. 15 manufacturers in China are registered for this product code.

Ascend

Anatomic Implant Extractor

Flat Nose Pliers

Flat Nose Pliers Double Action Serrated Jaws

Fitmore Extraction Adapter – F

Catalogue number SSI008207, listed by Zimmer, Inc., United States, under Extractor. 15 manufacturers in China are registered for this product code.

Recon Screw Extractor

Catalogue number 14-442099, listed by Biomet Orthopedics, United States, under Extractor. 15 manufacturers in China are registered for this product code.

Transverse Pin Extractor

Catalogue number SSI003834, listed by Zimmer, Inc., United States, under Extractor. 15 manufacturers in China are registered for this product code.

Vega System PS

Vega PS Fem.gauge Holder/Extractor

Impactor/extractor

Catalogue number 75.00.37, listed by Zimmer, Inc., United States, under Extractor. 15 manufacturers in China are registered for this product code.

Anterior Supine Stem Extractor

Catalogue number 31-555528, listed by Biomet Orthopedics, United States, under Extractor. 15 manufacturers in China are registered for this product code.

Endoskeleton® TCS

Bone Screw Extractor

Ortho Solutions Succession AFN System

Succession Extraction Adapter

The Tether Vertebral Body Tethering System

Sounder

LB 12/14 Taper Extraction Insert

Catalogue number SSI008214, listed by Zimmer, Inc., United States, under Extractor. 15 manufacturers in China are registered for this product code.

Nail Extractor Adapter

Catalogue number 14-441011, listed by Biomet Orthopedics, United States, under Extractor. 15 manufacturers in China are registered for this product code.

Irix-C Cervical Integrated Fusion System

Screw Removal Instrument Assembly

Orthopaedic Surgical Instruments

Catalogue number Universal nail extractor, listed by Citieffe SRL, Italy, under Extractor. 15 manufacturers in China are registered for this product code.

MaxAn Anterior Cervical Plate System

Extended Screw Remover

Orthopediatrics Instrumentation

Adolescent Nail Conical Extraction Adaptor

Extractor Lock

Catalogue number 14011, listed by Biomet Orthopedics, United States, under Extractor. 15 manufacturers in China are registered for this product code.

Moss

Moss Miami Spine System Distractor

Pipeline

Pipeline Access System Distractor

Pediatric Nailing Platform | Tibia

M7x1 Conical Extractor

K-Wire

Catalogue number 909827, listed by Biomet Orthopedics, United States, under Extractor. 15 manufacturers in China are registered for this product code.

Extractor

Modular Trunnion Opti-FIX Stem Extractor Adapter

SFS

Catalogue number 55-1070, listed by Orthofix US LLC, United States, under Extractor. 15 manufacturers in China are registered for this product code.

Precice® Intramedullary Limb Lengthening System Instrument

Orthopedic Manual surgical instrument (extractor)

Mallory/Head Modular Calcar

Catalogue number 429896, listed by Biomet Orthopedics, United States, under Extractor. 15 manufacturers in China are registered for this product code.

Comprehensive(R) Shoulder System

Catalogue number 406997, listed by Biomet Orthopedics, United States, under Extractor. 15 manufacturers in China are registered for this product code.

Fitmore Extraction Adapter – M

Catalogue number SSI008208, listed by Zimmer, Inc., United States, under Extractor. 15 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