Driver, Surgical, Pin

Which Manufacturers in China Make This?

12 manufacturers in China hold an FDA registration for this device type, concentrated in Guangdong, Zhejiang and Anhui, and 2 other provinces. 4 of them are contract manufacturers, able to build to a buyer’s own specification.

Apex (Guangzhou) Tools & Orthopedics Company Guangdong, contract manufacturer
Dongguan City Ruimi Gift Products Co Ltd Guangdong
Firstar Healthcare Company Limited (Guangzhou) Guangdong, contract manufacturer
Guangdong Comfort Medical Products Co., Ltd. Guangdong
Guangzhou Aquila Precise Tools Limited Guangdong, contract manufacturer
Guizhou Zirui Technology Co., Ltd. Guizhou
Hangzhou Rollmed Co., Ltd. Zhejiang, contract manufacturer
Ningbo Tianbo First AID Product Co., Ltd. Zhejiang
Planet (Anhui) International Co., Ltd. Anhui
Planet(Shanghai) International Co., Ltd. Shanghai
Yiwu Ori-Power Medtech Co., Ltd. Zhejiang, contract manufacturer
Zhejiang Biomet Medical Products Co., Ltd. Zhejiang, contract manufacturer

How Is GFC Classified?

Driver, Surgical, Pin is FDA product code GFC, 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 Do the Recalls Say?

The FDA has recorded 2 recalls under this product code since 2013. None was by a company in China. The root cause the FDA records most often is Device Design (1).

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

Driver, Surgical, Pin

PIN Setter

Catalogue number 1103-199, listed by Sontec Instruments, Inc., United States, under Driver, Surgical, Pin. 12 manufacturers in China are registered for this product code.

Driver, Surgical, Pin

Cassiopeia ACP

Temporary Fixation Pin Driver

Driver, Surgical, Pin

PNP Femur

PNP Screw Easy Off

Driver, Surgical, Pin

Pulsar

Recovery Driver

Driver, Surgical, Pin

Axial Bone Nail Driver

Catalogue number 32-349217, listed by Biomet Orthopedics, United States, under Driver, Surgical, Pin. 12 manufacturers in China are registered for this product code.

Driver, Surgical, Pin

K-Wires

K-Wire 0.7, 120mm

Driver, Surgical, Pin

Sontec PIN Driver/Bender

Sontec PIN Driver/Bender Double Ended Tips

Driver, Surgical, Pin

AnyPlus®

Cervical Cage Pin

Driver, Surgical, Pin

K-Wire PIN Driver

K-Wire PIN Driver Vise

Driver, Surgical, Pin

Vickers Easy Driver

Catalogue number 1103-179, listed by Sontec Instruments, Inc., United States, under Driver, Surgical, Pin. 12 manufacturers in China are registered for this product code.

Driver, Surgical, Pin

Calibrated Spade TIP Guide PIN

Catalogue number 110007425, listed by Biomet Orthopedics, United States, under Driver, Surgical, Pin. 12 manufacturers in China are registered for this product code.

Driver, Surgical, Pin

Piermattei PIN Driver/Bender

Catalogue number 1103-200, listed by Sontec Instruments, Inc., United States, under Driver, Surgical, Pin. 12 manufacturers in China are registered for this product code.

Driver, Surgical, Pin

Trinica/Trinica Select Anterior Cervical Plate System

Pin Inserter, Threaded

Driver, Surgical, Pin

Power Torque Instrumentation

5.5/6.0 Final Driver - Short

Driver, Surgical, Pin

PIN Driver

Catalogue number 1103-183, listed by Sontec Instruments, Inc., United States, under Driver, Surgical, Pin. 12 manufacturers in China are registered for this product code.

Driver, Surgical, Pin

Vickers K-Wire PIN Bender

Vickers K-Wire PIN Bender Black Coated

Driver, Surgical, Pin

Calibrated Spade Tip

Catalogue number 110007425, listed by Biomet Orthopedics, United States, under Driver, Surgical, Pin. 12 manufacturers in China are registered for this product code.

Driver, Surgical, Pin

Peterson PIN Driver/Bender

Peterson PIN Driver/Bender Double Ended Tips Fully Cannulated

Driver, Surgical, Pin

Cassiopeia Cervical Plate System

Temporary Fixation Pin Driver

Driver, Surgical, Pin

Apex Knee System

2 catalogue numbers from WS-30053, listed by Omni Life Science, Inc., United States, under Driver, Surgical, Pin. 12 manufacturers in China are registered for this product code.

Driver, Surgical, Pin

Pediatric Nailing Platform Femur

PNP End Cap Easy Out

Driver, Surgical, Pin

Tahoe Unicompartmental Knee System

Fixation Pin, Tri face with Tri Hub, OD 3.2mm, 4" Long

Driver, Surgical, Pin

UniSyn Hip System

Fixation Pin, Resection Guide, UniSyn

Driver, Surgical, Pin

TransFx®

Catalogue number 00-4450-093-00, listed by Zimmer, Inc., United States, under Driver, Surgical, Pin. 12 manufacturers in China are registered for this product code.

Driver, Surgical, Pin

Komet PIN Driver

8 catalogue numbers from GS900.130.000.K0, listed by Gebr. Brasseler Gmbh & Co. KG, Germany, under Driver, Surgical, Pin. 12 manufacturers in China are registered for this product code.

Driver, Surgical, Pin

Broken Screw Removal Instruments

Over-the-Head Screw Extractor, 6.75mm

Driver, Surgical, Pin

Butrex Buttress Plating System

Fixation Pin Holder, Assembly

Driver, Surgical, Pin

GluOn-IF

2 catalogue numbers from GS136-2460, listed by GS Medical Co., Ltd., South Korea, under Driver, Surgical, Pin. 12 manufacturers in China are registered for this product code.

Driver, Surgical, Pin

Consensus Knee System/Revision Knee System

Fixation Pin, w/Cut-Out, Ø 3.2mm., 4" Long

Driver, Surgical, Pin

OP Response Spine System

5.5/6.0 Closed Cannulated Pedicle Screw Driver, Zimmer Hudson

Driver, Surgical, Pin

PIN Driver/Bone Tamp

PIN Driver/Bone Tamp Single Ended Flat TIP

Driver, Surgical, Pin

Orthopediatrics Instrumentation

Direct Measuring Device - 3.2 x 300mm Wires

Driver, Surgical, Pin

PIN Driver

13 catalogue numbers from GS900.100.000.Q5, listed by Gebr. Brasseler Gmbh & Co. KG, Germany, under Driver, Surgical, Pin. 12 manufacturers in China are registered for this product code.

Driver, Surgical, Pin

Response 5.5/6.0 Cannulated Screw System

5.5/6.0 Cannulated Reduction Pedicle Screw Driver, T15, Zimmer Hudson Connect

Driver, Surgical, Pin

Pedinail

Threaded Trochar PIN (3.2 MM)

Driver, Surgical, Pin

PediNail Intramedullary Platform

Captured Screw Driver Shaft, 3.5MM, AO, Long

Driver, Surgical, Pin

K-Wire PIN Driver Vise

Titanium K-Wire PIN Driver Vise

Driver, Surgical, Pin

Driver, Surgical, Pin

Cleaning wire ø0.8, CS 2.0/2.7

Driver, Surgical, Pin

Driver, Surgical, Pin

Schanz Screw Rapid Driver FOR Mandible External Fixator II

Driver, Surgical, Pin

Insurgical, Inc.

3.2 - 4.0 Pin Driver Assembly

Driver, Surgical, Pin

Persona®

Catalogue number 42-5099-025-00, listed by Zimmer, Inc., United States, under Driver, Surgical, Pin. 12 manufacturers in China are registered for this product code.

Driver, Surgical, Pin

Tangis

Instrument, Fixation Pin, Threaded, Anterior Cervical Plating System (ACP)

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