Screwdriver

Which Manufacturers in China Make This?

10 of the 18 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
Changzhou Geasure Medical Apparatus AND Instruments Co., Ltd. Jiangsu, contract manufacturer
Changzhou Wastonortho Medical Appliance 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
Pengbo (Shenzhen) Medical Technology Co., Ltd. Guangdong
Paragon Medical Device (Changzhou) Co., Ltd. Jiangsu, contract manufacturer
Shandong Weigao Orthopaedic Device Co., Ltd. Shandong, contract manufacturer
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai, contract manufacturer
Shanghai Reach Medical Instrument Co., Ltd. Shanghai
Suzhou Endophix Co., Ltd. Jiangsu
Suzhou Microport Orthorecon Co., Ltd. Jiangsu, contract manufacturer
Suzhou Elite Precision Machinery Co., Ltd. Jiangsu, contract manufacturer
Xinhua Healthcare Industry Co., Limited Shandong, contract manufacturer
Zhejiang Biomet Medical Products Co., Ltd. Zhejiang, contract manufacturer

How Is HXX Classified?

Screwdriver is FDA product code HXX, 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 32 recalls under this product code since 2005. None was by a company in China. The root causes the FDA records most often are Device Design (8), Nonconforming Material/Component (7) and Process control (4).

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

Illico

Reduced Runout Illico Driver - Jacobs

Aprevo

aprevo® Cervical Straight Driver

UniSpace® Stand-Alone C Cage

7 catalogue numbers from AU0170, listed by CG MedTech Co., Ltd., South Korea, under Screwdriver. 18 manufacturers in China are registered for this product code.

Toro-L

Locking Rod Driver

Self – Retaining Driver T10

2 catalogue numbers from F003.0034, listed by Indius Medical Technologies PVT. Ltd., India, under Screwdriver. 18 manufacturers in China are registered for this product code.

Dyna Locking Ankle Nail

Catalogue number NA0020, listed by CG MedTech Co., Ltd., South Korea, under Screwdriver. 18 manufacturers in China are registered for this product code.

The Tether™

Bone Screw Driver

Perla

Perla Cannulated Locking Screwdriver

Nex-Link OCT Occipital Cervical Plating System

Locking Driver - Star Drive, AO Connection

Medicon Screwdriver

combi screwdriver percutaneous removeable long

Arcadius XP C

Arcadius XP C Hexalobe Ball JNT Screwdrv

Solidlok™hex TIP

Catalogue number 2810-01-019, listed by Biomet Orthopedics, United States, under Screwdriver. 18 manufacturers in China are registered for this product code.

Universal Screw Removal System

Blade, Screwdriver, NO. 2, 2.0/2.3 MM, Centredrive

Spinous Process System

T15 Driver

Ascend

Catalogue number SH0797, listed by Tornier Inc., United States, under Screwdriver. 18 manufacturers in China are registered for this product code.

MCI – Medical Concept Innovation, Inc.

Contra-Angle Screwdriver TIP FOR Membrane

IdentiTi

IDENTITi ALIF SA, T40 REMOVAL DRIVER, STRAIGHT, DRAW ROD

Conquest FN

Conquest FN 2-IN-1 HEX Driver - 4.7MM

Screwdriver HEX. 3,5 Mm Conn. Zimmer

2 catalogue numbers from H0150006099, listed by HPF SRL, under Screwdriver. 18 manufacturers in China are registered for this product code.

Trauma – Misc

Modified 6.5MM Cannulated Screw Driver

4WEB Medical

29 catalogue numbers from ASTS-SA-100022, listed by 4WEB Inc., United States, under Screwdriver. 18 manufacturers in China are registered for this product code.

T-Handle With A/O Adaptor

Catalogue number 24345, listed by Biomet Orthopedics, United States, under Screwdriver. 18 manufacturers in China are registered for this product code.

T25 Driver, Hudson

Catalogue number 101-0024, listed by OsteoCentric Technologies,Inc, United States, under Screwdriver. 18 manufacturers in China are registered for this product code.

Screwdriver

Flat Foot Screwdriver and Positioner

MIS T25 Super Locking Driver

Catalogue number 101-0031, listed by OsteoCentric Technologies,Inc, United States, under Screwdriver. 18 manufacturers in China are registered for this product code.

INT-FIX

Modified T7 Driver With AO Quick Connect

VItal Spinal Fixation System

Cann Tower Algn Tool Head Turn

Streamline® MIS Spinal Fixation System

Streamline MIS, Screw Inserter, Threaded

Tibiaxys Ankle Fusion Plating System

Hexagonal Screwdriver FOR 4.5MM Screw

Daytona

Cannulated DLTA Driver, Extra Short Jacobs

Capture High Torque Screw System

T25 Driver. 5.0MM Screw

Hex Ball End Screwdriver

Catalogue number 32-467201, listed by Biomet Orthopedics, United States, under Screwdriver. 18 manufacturers in China are registered for this product code.

Integra®

Integra® Total Foot System The TX 8 non-cannulated driver with AO is used in conjunction with the Integra Total Foot system.

Equinoxe

3.5mm HEX DRIVE RATCHET WRENCH, CONNECTION

Screwdriver

Driver Handle, Ratcheting, Straight

HPS Set-Screw Driver

Catalogue number HAT80300, listed by Paradigm Spine GmbH, Germany, under Screwdriver. 18 manufacturers in China are registered for this product code.

Removal Driver

Catalogue number 17149, listed by Biopro, Inc., United States, under Screwdriver. 18 manufacturers in China are registered for this product code.

ComposiTCP

ComposiTCP Modular driver to be used with ComposiTCP interference screws of diameter 9, 10 and 11 mm in ACL reconstruction.

Cortera

Set Screw Starter, Lock, Exp, SUB, Shaft

Otis

Screwdriver for OTIS® screw extraction

Panta®

The hexagonal screwdriver tip with AO attachment is used to implant or explant screws.

Driver Bushing

3 catalogue numbers from 471432, listed by Biomet Orthopedics, United States, under Screwdriver. 18 manufacturers in China are registered for this product code.

Screwdriver

Screwdriver, Handle 25mm, WS 2.5, L=120mm. Can. 1.7mm

Silverton Spinal Fixation System

Modified Bone Screw Driver Shaft Locking

Endoskeleton® TCS

Driver 5210-1004 TCS NO 8 HEX Straight

Dynesys Dynamic Stabilization System

Set Screw Driver With Spring Clip Assembly

Quick-Start

Quick-Start Screwdriver 3.5mm Hex, 2.0mm Cannulation

Scheker Druj

1.5mm Hex Head Allen Wrench

Screwdriver

Angled Hexagonal Screwdriver

T15 Drivers

T15 Non-Retaining Removal Driver, Short

Viper® Distal Volar Radius Plating System

Valt Placement Driver

Tandry Orthopedic Manual Surgical Instrument

Self-Retaining Hexalobular T15 Cannulated Screwdriver

Minirail

Square Pin Driver with Quick Connect 2.5mm

Legion

Legion Hinge 4.75MM HEX Driver

UNI-Thread®

Short Shaft for Pedicle Screwdriver

MEGA5.5 Spine System

Multi-axial Long-arm Screw Driver

Cortium

Screwdriver, cannulated, with SR15, AO Coupling

Virage OCT Spinal Fixation System

Occipital Final Driver, Flexible

Moss

Moss Miami Spine System Polyaxial Driver Reduction

Trestle Luxe

Inner Shaft, Hexalobe Screw Removal Tool

VerteFIT

Catalogue number VerteFIT, listed by Ldr Spine USA, United States, under Screwdriver. 18 manufacturers in China are registered for this product code.

Optima™ Spinal System

13 catalogue numbers from SP0022, listed by CG MedTech Co., Ltd., South Korea, under Screwdriver. 18 manufacturers in China are registered for this product code.

DSS™ Tray for Nut, Spacer & Washer

Catalogue number DAT00500, listed by Paradigm Spine GmbH, Germany, under Screwdriver. 18 manufacturers in China are registered for this product code.

Mondeal

MCD blade M4 for 200 mm K-Wire cannulated not self-retaining AO 1 x red

Slimplicity Anterior Cervical Plate System

Slimplicity Driver, AO Connect, 5.5"

Arsenal

Cannulated Long Locking Polyaxial Reduction Screwdriver

Zespin SI Joint Fusion System

Locking Screw Driver

Dyna Locking IM Nail

3 catalogue numbers from IN1024, listed by CG MedTech Co., Ltd., South Korea, under Screwdriver. 18 manufacturers in China are registered for this product code.

Surfix®

The SURFIX® hexagonal screwdriver is used to mill the bone to introduce the collar of the screw and to screw screws and lock screws. It is also used to remove screws and lock screws.

S4 Cervical

S4C Dbl.ended SET Screw Starter W/Spring

Shukla Spine-CTL S9SPINE-CTL,Shukla Spine-C S9SPINE-C

Driver Assy, Male, Hex, Reverse Captive, 3.5mm : For S9SPINE , Spc. Order

Zodiac

Zodiac High TOP Polyaxial Screwdriver

Tryptik Instrumentation

2 catalogue numbers from MOS-IN 00 10-N, listed by Spineart SA, Switzerland, under Screwdriver. 18 manufacturers in China are registered for this product code.

Cruciform Screwdriver Sleeve

Catalogue number 1106-289C, listed by Sontec Instruments, Inc., United States, under Screwdriver. 18 manufacturers in China are registered for this product code.

Coral

Standard Screw Inserter-Rotating Sleeve

Medline

Guidewire, NON-Threaded, 1.6 X 150MM

Cannulated Hex Screwdriver

4 catalogue numbers from 906845, listed by Biomet Orthopedics, United States, under Screwdriver. 18 manufacturers in China are registered for this product code.

KMI Instruments

2.5MM Manual HEX Driver

Delta CTA

Delta CTA Hexagonal Screwdriver 2.5 MM

HEX Screwdriver

6 catalogue numbers from 904307, listed by Biomet Orthopedics, United States, under Screwdriver. 18 manufacturers in China are registered for this product code.

Malibu

Cannulated Poly Driver, Modular Shaft 8.0+

MP Reconstruction System – Instruments

Surgical screwdriver, reusable - MP Reconstruction System

Optima™ ZS Spinal System

5 catalogue numbers from SP0024, listed by CG MedTech Co., Ltd., South Korea, under Screwdriver. 18 manufacturers in China are registered for this product code.

Mariner MIS Tlif Retractor

Shank/Blade Driver, Short

Ti6 Internal Fixation System

TS-Series Countersink FOR 2.0 & 2.5MM Screws - AO

Screwdriver

Troch Nail, Ball Locking Hex Driver, Nail

Alcantara Thoracolumbar Plating

T10 Blocking Screw Driver

Pilling

7 catalogue numbers from IPN924079, listed by Teleflex Medical LLC, United States, under Screwdriver. 18 manufacturers in China are registered for this product code.

General Instruments

Reduction Polyaxial Screwdriver, Locking Modified 1/4" Square 2 Flat

Easy OUT, S-Couple

2 catalogue numbers from 8241-59-000, listed by Biomet Orthopedics, United States, under Screwdriver. 18 manufacturers in China are registered for this product code.

Titan

Ttitan Mini Interference Screw Driver 1/4" Quick Connect, Short

3.5MM HEX A/O Connect (Short)

Catalogue number 24365, listed by Biomet Orthopedics, United States, under Screwdriver. 18 manufacturers in China are registered for this product code.

TC-100

HEX Screwdriver Shaft Large

MatrixMIDFACE

Matrixmidface Screwdriver BLD Self-Retaining F/90° Scrwdrvr

CosmoLock Pedicle Screw System

Screwdriver, Polyaxial, Standard, Cannulated, Lockable, SNI 1 Assembly

Evos

Evos Distal Radius 2.5MM Fixed Handle Tapered HEX Driver

Daytona® Small Stature

Locking Driver Shaft, Tri-Flat, Small Stature

Sternalock (TM) System

3 catalogue numbers from 71-1196, listed by Biomet Microfixation, United States, under Screwdriver. 18 manufacturers in China are registered for this product code.

Summa Orthopaedics System Surgical Instrument

25 catalogue numbers from SO-113-HF-603, listed by Jeil Medical Corporation, South Korea, under Screwdriver. 18 manufacturers in China are registered for this product code.

Autofix

Cannulated T7 Driver Shaft, QC fitting

Paeon Posterior Cervical Fixation System

Torque Limiting Driver

Simple Locking Intramedullary (Slim) System

SLIM DRIVER FOR Ø4.0, 4.8, 5.6 & 6.4 mm RODS

L1 Reconguide

Handle, Screwdriver, Flat, RED, 2.0/2.3/2.7 MM Screw

OrthoSolutions ‘System26’ Bone Screws

Driver FOR 5.0MM Screw Cannulated T20 Jacobs QC

AMP

LIF AMP, Center Screw Driver, Short

Staple Shaft

Catalogue number 242-152-003, listed by Signature Orthopaedics PTY Limited, Australia, under Screwdriver. 18 manufacturers in China are registered for this product code.

Screwdriver

34 catalogue numbers from 4502-25, listed by Zimmer, Inc., United States, under Screwdriver. 18 manufacturers in China are registered for this product code.

Polaris 4.75 Deformity System

4.75 TI Clsd Head MAS Inserter

Laminoplasty

Stop Drill, 11mm L

Velofix™ Tlif Cage

5 catalogue numbers from TL0210, listed by CG MedTech Co., Ltd., South Korea, under Screwdriver. 18 manufacturers in China are registered for this product code.

Pass ANT

Screwdriver Shaft FOR Polyaxial Bone Screw

Operace

Sterile single use insert for the removal of intact screws

Complete Cervical Stand Alone IBD

Self Retaining Screw Inserter

Prima™ OCT Spinal System

4 catalogue numbers from SO0160, listed by CG MedTech Co., Ltd., South Korea, under Screwdriver. 18 manufacturers in China are registered for this product code.

Tools – Screws

Hex Driver 3.5, 130mm Cannulated TriLobe

Delta Xtend

DELTA XTEND Peripheral locking screwdriver outer shaft with handle

Sampedro

Cannulated screwdriver hexalobe T8 AO

LineSider

Flats Stab and Grab Driver 5.5-6.0 Tulip

Overwatch

Quick Lock Screw Driver, Short Cannulated Inner Shaft

Extension Counter Torque

Catalogue number 101-0019, listed by OsteoCentric Technologies,Inc, United States, under Screwdriver. 18 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