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.

Silex Sacroiliac Joint Fusion System

SPECIAL 7mm ADJUSTMENT IMPLANT DRIVER, CANNULATED

3/8 HEX Socket A/O Connect

Catalogue number 24330, listed by Biomet Orthopedics, United States, under Screwdriver. 18 manufacturers in China are registered for this product code.

Simple Driver (Black)

Catalogue number 242-152-020, listed by Signature Orthopaedics PTY Limited, Australia, under Screwdriver. 18 manufacturers in China are registered for this product code.

Symphony

Symphony OCT System Polyaxial Screw Driver Shaft X20, Cannulated, Short

SFS

Multi-Axial Reduction Screwdriver Reduction Pedicle Screw

Versi.ISI Univ.Biosteon Dr.Shaft,Trinkle

Versi.ISI Univ.Biosteon Dr.Shaft,Trinkle: 1 catalogue number listed by T.A.G Medical Products Agricultural Cooperative Association, under Screwdriver. 18 manufacturers in China are registered for this product code.

Small Hex Driver Cann Hud-Mod

Catalogue number 202-0402, listed by OsteoCentric Technologies,Inc, United States, under Screwdriver. 18 manufacturers in China are registered for this product code.

Shukla Anterior Hip S9HIP-ANT

Driver, Phillips, #3, Stubby

Annex® 2 Adjacent Level System

Locking Screw Inserter, T25

Internal Fixation

Long T7 Driver With AO Quick Connect

Paeon Anterior Cervical Plate System

2 catalogue numbers from CP02-0704, listed by Aegis Spine, United States, under Screwdriver. 18 manufacturers in China are registered for this product code.

MatrixNEURO

Matrixneuro Screwdriver Blade HEX Coupling/Self-Retain/Short

Mariner MIS

MIS Extended Tab Navigation Driver

Screw Driver Shaft

Catalogue number 1106-284, listed by Sontec Instruments, Inc., United States, under Screwdriver. 18 manufacturers in China are registered for this product code.

Screwdriver HEX. 3,5 Mm

4 catalogue numbers from H0150004599, listed by HPF SRL, under Screwdriver. 18 manufacturers in China are registered for this product code.

Epix Anti-Rotation Cap Driver

Catalogue number 5000-00340, listed by Epix Orthopaedics Inc., under Screwdriver. 18 manufacturers in China are registered for this product code.

P.F.C.

P.F.C. Modular Plus Wedge Trial Screwdriver

Zimmer® Minimally Invasive Solutions™ Hip Instrumentation

Catalogue number 9375-00-032, listed by Zimmer, Inc., United States, under Screwdriver. 18 manufacturers in China are registered for this product code.

Acura Stabilization System – Rigid Screw Driver,SNAP ON (NT)

Rigid Screw Driver, SNAP ON (NT)

Universal Screwdriver Small

Catalogue number 424423, listed by Biomet Orthopedics, United States, under Screwdriver. 18 manufacturers in China are registered for this product code.

Screwdriver

4 catalogue numbers from 8210-56-000, listed by Biomet Orthopedics, United States, under Screwdriver. 18 manufacturers in China are registered for this product code.

Stabolt

U-Joint Self Retaining Screwdriver

R3

Standard HEX Driver

Straight Ratcheting Handle

Catalogue number 101-0032, listed by OsteoCentric Technologies,Inc, United States, under Screwdriver. 18 manufacturers in China are registered for this product code.

Screwdriver

Cannulated Screwdriver

Biodrive Cannulated Screw SYS

6 catalogue numbers from 14-450215, listed by Biomet Orthopedics, United States, under Screwdriver. 18 manufacturers in China are registered for this product code.

NexFix

Self Retaining Driver

Plasmacup

Plasmacup Articulated Screw Driver SW3.5

2.4MM TMS System

3 catalogue numbers from 24-1393, listed by Biomet Microfixation, United States, under Screwdriver. 18 manufacturers in China are registered for this product code.

Ringfix

Silicone Handle Pin Inserter, GEN II

Valkyrie Thoracic Fixation System

Driver Bit, No Shoulder

Locon-T

2 catalogue numbers from 24900023, listed by Wright Medical Technology, Inc., United States, under Screwdriver. 18 manufacturers in China are registered for this product code.

Ascent

Mini Multi-Axial Screw Driver, Ascent Poct

Balboa

3mm Screwdriver, Non-Tapered

Hexagonal U-Joint Screwdriver 3.5mm

Catalogue number T2685, listed by MPS Micro Precision Systems AG, Switzerland, under Screwdriver. 18 manufacturers in China are registered for this product code.

Vilex Jones Fracture Tool

Driver, Jones T20 Hexalobe, Solid, Non Self Retaining

Lactosorb® 2.0MM System

3 catalogue numbers from 915-2065, listed by Biomet Microfixation, United States, under Screwdriver. 18 manufacturers in China are registered for this product code.

Cardan Screwdriver HEX. 3,5 Mm

2 catalogue numbers from 01.26.10.0011, listed by HPF SRL, under Screwdriver. 18 manufacturers in China are registered for this product code.

MI (Mini Incision) Driver – Red

Catalogue number 192-102-121, listed by Signature Orthopaedics PTY Limited, Australia, under Screwdriver. 18 manufacturers in China are registered for this product code.

Targon

Targon Screw Driver SW4.5 W/Hexag.shank

Spine System

3 catalogue numbers from 8734-4270, listed by Biomet Spine, United States, under Screwdriver. 18 manufacturers in China are registered for this product code.

Mega Plus MIS Spine System

Cannulated Long-Arm Multi-Axial Screw Driver

Pinnacle

Pinnacle Make TO Order Dual Offset CUP Impactor Driver Assembly

Battalion

Blade Toe Driver for LLIF Retractor

SkyOPS

Screwdriver Bit, T6 Tapered

Quickset

Quickset Tapered HEX Screwdriver U-Joint

PathFinder NXT Minimally Invasive Pedicle Screw System

5/64" Male Hex Screwdriver II

Cross-Fuse® II PEEK VBR/IBF System

Angled Inserter

Spider Cervical Plating System

NON-Ratcheting T-Handle Mini AO Driver

Trinica/Trinica Select Anterior Cervical Plate System

Cervical Plate, Driver, Hex, Ball End, Assembly

Acura Stabilization System – Rigid Screw Driver (NT)

Rigid Screw Driver - NT

Neofuse

Drill 2IN1 Diam 4.3/5.8 LG145 NO Sterile Cannulated 2.0 MM

Nutdriver, HEX

Catalogue number 8250-01-000, listed by Biomet Orthopedics, United States, under Screwdriver. 18 manufacturers in China are registered for this product code.

Irix-A Lumbar Integrated Fusion System

Irix A Universal Joint Guided HEX Driver Assembly

Medlineunite

Driver, Retaining, AO/QC, T15

Pathway

Pathway Disassembly Driver

Aegis

Aegis Anterior Lumbar Plate Screwdriver, Self-Retaining

Cable-Ready®

Catalogue number 2232-06, listed by Zimmer, Inc., United States, under Screwdriver. 18 manufacturers in China are registered for this product code.

Flow-Nail™

FN Lag Screw Driver

Comprehensive® Reverse Shoulder

Catalogue number 110040301, listed by Biomet Orthopedics, United States, under Screwdriver. 18 manufacturers in China are registered for this product code.

Anax™ OCT Spinal System

6 catalogue numbers from OS0160, listed by CG MedTech Co., Ltd., South Korea, under Screwdriver. 18 manufacturers in China are registered for this product code.

TC-Plus Revision / RT-Plus

TC Revision/RT/RT Modular Chisel Handle

APR®

2 catalogue numbers from 9310-10-201, listed by Zimmer, Inc., United States, under Screwdriver. 18 manufacturers in China are registered for this product code.

CoverLoc

#8 Star Screw Driver BIT

Vilex Tool

Orthex, Hex Driver, 3mm

Vault C Acdf System

Angled Self-Retaining Driver (2)

Active Compression

T25 Cannulated Driver, Active Compression

GEO Bone Screw System

Driver Handle AO Fixed Spinner Straight Reusable

Katalyst Bipolar Radial Head System

HEX Driver. 2.5MM

Screwdriver Ini

Catalogue number A06 005, listed by Z-Medical Gmbh & Co. KG, Germany, under Screwdriver. 18 manufacturers in China are registered for this product code.

Universal Chuck T Handle

Catalogue number 110350, listed by OsteoCentric Technologies,Inc, United States, under Screwdriver. 18 manufacturers in China are registered for this product code.

GPC

Cannulated Screw Driver-Tip 2.5 mm (for 3.5/4.0 mm Screws)

Mini Fragment SET Screwdriver Shaft

Catalogue number 939999473, listed by Biomet Orthopedics, United States, under Screwdriver. 18 manufacturers in China are registered for this product code.

Ocata Anterior Cervical System

Screw Driver, Cannulated Assembly

Jazz

Hexagonal 3.5 EVO Screwdriver

AnyPlus®

AnyPlus Poly Screw Driver Cannulated, Torx Type

IQ

IQ Screw Driver SW4.5

T25 Screw Driver

2 catalogue numbers from 21390, listed by Biopro, Inc., United States, under Screwdriver. 18 manufacturers in China are registered for this product code.

Flexible Hex Driver

Catalogue number 27962, listed by Biomet Orthopedics, United States, under Screwdriver. 18 manufacturers in China are registered for this product code.

Screwdriver Pedicle Screw

Catalogue number A06 006, listed by Z-Medical Gmbh & Co. KG, Germany, under Screwdriver. 18 manufacturers in China are registered for this product code.

Ex-Fix

Swivel 10mm Socket 1/4 Drive

Trigen MAX

Trigen MAX 3.5MM Tibia Compression SET Screw Hexdriver

CS2 Acetabular System

Flexible Drilling Shaft, 60°, Assembly

Optio-C Anterior Cervical System

2.0 mm Hex Driver, U-Joint

Threaded Hand Nail

T10 Driver, AO, Cannulated, Reusable

Prometheus System Surgical Instrument

12 catalogue numbers from PRO-90012, listed by Jeil Medical Corporation, South Korea, under Screwdriver. 18 manufacturers in China are registered for this product code.

3.5mm/2.5mm Universal Drill Sleeve

Catalogue number 110522, listed by OsteoCentric Technologies,Inc, United States, under Screwdriver. 18 manufacturers in China are registered for this product code.

Precice® Trauma Nail System

Cannulated 3.5mm Hex Screw Driver, Short

CorticaLINK

FacetLINK Screwdriver Shaft 1of 2

Cross-Fuse® PEEK VBR/IBF System

6 catalogue numbers from 35-INSERTER-18, listed by Pioneer Surgical Technology, Inc., United States, under Screwdriver. 18 manufacturers in China are registered for this product code.

TensionTac Insertion Tool

Catalogue number DFX0044T, listed by Dunamis Medical LLC, United States, under Screwdriver. 18 manufacturers in China are registered for this product code.

Trauma-Internal Fix

T25 Screwdriver ONE Piece

Tether

Catalogue number 6201-00, listed by Interventional Spine, Inc., United States, under Screwdriver. 18 manufacturers in China are registered for this product code.

Mountaineer

Mountaineer OCT Spinal System Final Tightener Driver Shaft X25

SPH Screwdriver HEX. 3,5mm

Catalogue number 9084.20.210, listed by HPF SRL, under Screwdriver. 18 manufacturers in China are registered for this product code.

Redemption

Ratcheting Straight Handle (off the shelf)

Summit

Summit SI OCT Spinal Fixation System Polyaxial Screwdriver

Screwdriver

Hex 3.5mm Retentive Straight Screwdriver -Zimmer Connection

3p Hip System

3P 4.5mm Cannulated Hex Driver Small T-Handle

IBS™

Cannulated Screwdriver T7-L Measuring Function

Sure-Lok Pedicle Screw System

Polyaxial Screwdriver Cannulated

DJO Surgical

AltiVate Reverse Glenoid Peripheral Screw T20 Driver

Apex

Short Screw Driver With Retention Hex (3.5mm)

Benefix™ Interspinous Fixation System

4 catalogue numbers from ISS1003, listed by CG MedTech Co., Ltd., South Korea, under Screwdriver. 18 manufacturers in China are registered for this product code.

HALLU-Lock M.T.P. Arthrodesis System

Torx T7 Screwdriver Blade - AO TIP

ABC

ABC Screw Segment Breaker, non-sterile, reusable

Screwdriver Shaft

Screwdriver Shaft Hexagonal 3.5 Millimeter Large Size

Momentum MIS

Double-sided self-retaining locking screwdriver

Emerge Medical & Design

Cannulated Driver FOR Threaded Washers F/3.0MM Cann Screws

Shukla Nail S9NAIL

Driver Assy, Hex, Male, 2.5 mm

Dyna Locking Trochanteric Nail

20 catalogue numbers from NG3013, listed by CG MedTech Co., Ltd., South Korea, under Screwdriver. 18 manufacturers in China are registered for this product code.

General Instruments

Cannulated Hexagonal Screwdriver AO TIP 2MM

Arcos®

Catalogue number 31-301880, listed by Biomet Orthopedics, United States, under Screwdriver. 18 manufacturers in China are registered for this product code.

Drive Rail System

10mm Driver, Square Drive

Universal Clamp™

2 catalogue numbers from SN2027-1-02512, listed by Zimmer Spine, Inc., United States, under Screwdriver. 18 manufacturers in China are registered for this product code.

Total Wrist Fusion System

2.5MM Self-Retaining HEX Driver

Zimmer® Cannulated Screw System

CANNULATED HEXAGONAL DRIVER, 5.0mm TRINKILE

Humeral Screwdriver

2 catalogue numbers from 2810-17-017, listed by Biomet Orthopedics, United States, under Screwdriver. 18 manufacturers in China are registered for this product code.

Free Gliding Scfe Screw System

SCFE HANDLE-SHAFT SUBASSY Ø7.3mm - MINI

3.5MM Instr Cnctr LO PRO Long

Catalogue number 14-441049, listed by Biomet Orthopedics, 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