Orthopedic › Diagnostic

Who Makes It in China?

53 manufacturers in China hold an FDA registration for a device type in this section, concentrated in Guangdong, Jiangsu and Zhejiang, and 5 other provinces. 20 of them are contract manufacturers. Chinese manufacturers are registered for 6 of 12 device types here.

5 of those 6 device types need no premarket submission before sale in the United States. The FDA has recorded 184 recalls across the section’s product codes; the root causes it names most often are Packaging process control (24), Nonconforming Material/Component (24) and Packaging (23).

Which Device Types Are Made in China?

The device types with the most Chinese manufacturers are Arthroscope (21), Accessories, Arthroscopic (14), Goniometer, Nonpowered (14), Dynamometer, Nonpowered (5) and Goniometer, Ac-Powered (4). All 6 device types in this section with a Chinese manufacturer, most manufacturers first:

Arthroscope 21 manufacturers
Accessories, Arthroscopic 14 manufacturers
Goniometer, Nonpowered 14 manufacturers
Dynamometer, Nonpowered 5 manufacturers
Goniometer, Ac-Powered 4 manufacturers
Dynamometer, Ac-Powered 2 manufacturers

Kyphon Express II KyphoPak Tray

Bone Tamp KIT KEX152EB FF E2 15/2 OI

Accessories, Arthroscopic

Reprocessed 4.0mm Rad 40 Curved Blade, Rotatable

Reprocessed 4mm Rad 40 Curved Blade, Rotatable

Curved Standard Shaver XL 4.2 Mm

Catalogue number R-10026, listed by Relign Corporation, United States, under Arthroscope. 21 manufacturers in China are registered for this product code.

Tubing Set – Single Lumen, Inflow With Dual Outflow

Catalogue number LL0004, listed by Thermedx, LLC, United States, under Arthroscope. 21 manufacturers in China are registered for this product code.

Reprocessed 5.5mm AcromioBlaster Burr, Brick Red

Catalogue number 7205669, listed by Suretek Medical, United States, under Arthroscope. 21 manufacturers in China are registered for this product code.

Accessories, Arthroscopic

2.7 Mm Endoscopic Release System

2.7 mm KNIFE & CLEAR CANNULA COMBO PACK

Accessories, Arthroscopic

15DEG Bankart Rasp

Catalogue number 904804, listed by Biomet Orthopedics, United States, under Accessories, Arthroscopic. 14 manufacturers in China are registered for this product code.

PowerPumpTM Dp System Interface Cable, Type 1

Compatible with: S&N Dyonics Power, Dyonics Power 2

24k

Tube SET 24K True Intra-Articular Pressure Sensing

Accessories, Arthroscopic

Maci Arthroscopic Instruments

17 mm x 28 mm Max Arthroscopic Cutter and 17 mm x 28 mm MACI Cutter Kit

Accessories, Arthroscopic

Reprocessed 5.5mm CoolCut Sabre Blade

5.5mm CoolCut Sabre Blade

Dynamometer, Nonpowered

General Instrument

General Instrument - Torque Wrench Zimmer Connection 10Nm

Joinix Cannula System

The Joinix Cannula System provides a portal for introducing surgical instruments during orthopedic procedures. A trocar punctures tissue to create the access path, and the cannula forms the…

Kyphon® One-Step™ System, Trocar & Diamond and BFD

IBT KIT KPX203PB-A FF X2 20/3 1 STP

Goniometer, Nonpowered

Medline

GONIOMETER,PLASTIC,360 DEG,8 IN

Iris Arthroscope

HD3 Arthroscope 4.0 mm autoclavable 30

Endoscope

4K UHD Foraminoscope XT (3.7 WCh), ocular

Accessories, Arthroscopic

SharpShooter

Cannula, Right Posterior

Accessories, Arthroscopic

PressFT

PressFT Flex Straight Drill Guide, Hip

SDC3

Device Control Package

Balloon Kyphoplasty Essentials

KIT NH102PB 10/2 Spine Essen FF

Goniometer, Ac-Powered

Ultium

Ultium Motion Sensor Strap (Large, Wide)

Cessys®

CESSYS® Dorsal FHD Laminoscope (4.7 WCh), ocular

Accessories, Arthroscopic

SureLock®

6 catalogue numbers from CM-9643, listed by Cayenne Medical, Inc., United States, under Accessories, Arthroscopic. 14 manufacturers in China are registered for this product code.

Goniometer, Nonpowered

Delta Xtend

Delta Xtend 145 RSA Goniometer

Accessories, Arthroscopic

Reprocessed 2.9mm Full Radius Resector

2 catalogue numbers from C9944A, listed by Suretek Medical, United States, under Accessories, Arthroscopic. 14 manufacturers in China are registered for this product code.

Accessories, Arthroscopic

Bonecam

Obturator, Sharp

Accessories, Arthroscopic

Bioraptor

Bioraptor 3.0 MM T-Handle Manual Drill BIT With Depth Stop FOR Bioraptor 2.9 MM Anchor

Goniometer, Ac-Powered

myoMOTION

myoMOTION Sensor Charging Station

Accessories, Arthroscopic

FlowPort

Flowport II Cannula With Obturator Linvatec AND Storz

Aesculap

MIASPAS MINI-TTA Diaphragm Retractor Blade, fixable, Size S, depth: 110 mm, width: 35 mm, titanium, with ball snap closure, non-sterile, reusable

InflateFX™ Gen II Fracture Management

Bone Tamp E103A 10/3 A LA Carte

SpineJet®

SpineJet® Percutaneous Hydrodiscectomy Set with Access Set

Accessories, Arthroscopic

Vario 18 AC 50HZ EU

Vacuum Pump Truclear Office EU

Tube Set for C7050 Irrigation Console

Catalogue number Z0449-32, listed by W.O.M. World of Medicine GmbH, United States, under Arthroscope. 21 manufacturers in China are registered for this product code.

Accessories, Arthroscopic

Reprocessed 2.9mm Inferior Turbinate Blade, Rotatable

Reprocessed 2.9mm Inferior Turbinate Blade, Rotatable, without Tubing

Accessories, Arthroscopic

Reprocessed 5.5mm Acromionizer Bur

Catalogue number 7205327, listed by Suretek Medical, United States, under Accessories, Arthroscopic. 14 manufacturers in China are registered for this product code.

Accessories, Arthroscopic

Reprocessed 5.5mm Excalibur Cool Cut Shaver Blade

Catalogue number AR-8550EX, listed by Suretek Medical, United States, under Accessories, Arthroscopic. 14 manufacturers in China are registered for this product code.

Accessories, Arthroscopic

Endobutton

2.4 MM Flexible Passing Pins, Sterile 5 PER Package

Accessories, Arthroscopic

Lite Profile

Lite Profile Endoscopic Release System

Arthroscope

Accessories 9560106 Mtrx V-MNT TO C-MNT

Accessories, Arthroscopic

One-Way Tap

Stopcock for Foraminoscope

Double Pump RF

Double Pump RF Patient Cassette 20/BX

IntraVu Scope 60

Kit containing 60mm Scope and 60mm Cannula, 60mm Trocar, and Stopcock. IntraVu Scope is a miniaturized, sterile, single-use, disposable scope for use with the IntraVu Tablet reusable video…

Goniometer, Ac-Powered

E-Vive Nmes System; Large/XL, Right, Bilateral Kit

Catalogue number CY-1000-240, listed by Motive Health, Inc., United States, under Goniometer, Ac-Powered. 4 manufacturers in China are registered for this product code.

KyphPak® First Fracture Tray

KIT KPX203PB-CDS 20/3 FF 1-STEP With CDS

Accessories, Arthroscopic

Reprocessed 5.0mm CoolCut SabreTooth Blade

5.0 mm x 12.5 cm SabreTooth Blade

Arthroscope

RFB, 4MM, 30 Degree HD Quicklatch Autoclavable Cartridge Scope

Arthroscope

Adapter, Acmi/British STD FOR 01-03730

Trocar

14 catalogue numbers from 191 401 755BC, listed by Sopro-Comeg GmbH, Germany, under Arthroscope. 21 manufacturers in China are registered for this product code.

Accessories, Arthroscopic

Quick-Latch

Quicklatch Sheath Body, Nonfenestrated, 5.8MM, 30 DEG/ 70 DEG

Accessories, Arthroscopic

Biceptor

Refurbished Biceptor Driver

Sterile Micro Hook Blade, Edin I

Catalogue number 4058, listed by Restore Surgical LLC, under Arthroscope. 21 manufacturers in China are registered for this product code.

Accessories, Arthroscopic

CinchLock Flex

Cinchlock Flex 20 DEG Slant Drill Guide

Accessories, Arthroscopic

Reprocessed 5.0mm Resector Cutter

Catalogue number 375-552-000, listed by Suretek Medical, United States, under Accessories, Arthroscopic. 14 manufacturers in China are registered for this product code.

Accessories, Arthroscopic

Reprocessed 4mm Skimmer Angle Tip Blade, 22.5cm

Reprocessed 4mm Skimmer Angle Tip Blade, 22.5cm, with Tubing

Accessories, Arthroscopic

Bone Tamp

Catalogue number 909897, listed by Biomet Orthopedics, United States, under Accessories, Arthroscopic. 14 manufacturers in China are registered for this product code.

AnchorEntry Retractor, Expander Blades, 60 Mm

Catalogue number PSZ-200-209, listed by Baylis Médicale Cie Inc, under Arthroscope. 21 manufacturers in China are registered for this product code.

Accessories, Arthroscopic

Reprocessed 2.9mm Small Joint Incisor Plus Elite Blade, 7cm

Catalogue number 72201513, listed by Suretek Medical, United States, under Accessories, Arthroscopic. 14 manufacturers in China are registered for this product code.

Dyonics 25

Svce Repl Dyonics 25 Wireless Remote

AnchorEntry Retractor, 80 Mm

Catalogue number PSZ-200-203, listed by Baylis Médicale Cie Inc, under Arthroscope. 21 manufacturers in China are registered for this product code.

TAC-S/Eflex

TAC-S E-Flex Vulcan

Accessories, Arthroscopic

Reprocessed 4.0mm Skimmer Angle Tip Blade, 22.5cm, Rotatable

Reprocessed 4mm Skimmer Angle Tip Blade, 22.5cm Rotatable, without Tubing

Drill

Drill, 220mm×9G

Goniometer, Nonpowered

Ambassador

Ambassador,Barrel fixation pin,5mm

Accessories, Arthroscopic

CAP-FIX

HIP-PAC CAP-FIX Blade Straight

Epiduroscopy Introducer Set

2 catalogue numbers from 4007, listed by Myelotec, United States, under Arthroscope. 21 manufacturers in China are registered for this product code.

Mendec® Kypho Set Monolateral 10 Mm

Catalogue number ASB030A, listed by Tecres SPA, Italy, under Arthroscope. 21 manufacturers in China are registered for this product code.

Accessories, Arthroscopic

Accessories, Arthroscopic

Instrument X0905351 Left Half TUBE130MM

DrillCut-X

DRILLCUT-X® ARTHRO Shaver Handpiece

Goniometer, Ac-Powered

MyoVision Wirefree System

PhysioMonitor Hub with FlexVision Inclinomters DynaVision Dynamic sEMG and ScanVision Lite Static sEMG Scanner

Accessories, Arthroscopic

Medline Renewal

214116 @thrd Clear CAN W/Obturator, (PUR

TabletVu

TabletVu is a reusable visualization system for use with the IntraVu Scope.

Accessories, Arthroscopic

Vector

Micro Vector K-Wire Guide FOR.062 Inch K-Wire

Accessories, Arthroscopic

Reprocessed 4.5mm RADenoid Adult Blade, Curved

Catalogue number 18-84507, listed by Suretek Medical, United States, under Accessories, Arthroscopic. 14 manufacturers in China are registered for this product code.

Accessories, Arthroscopic

Reprocessed 2.9mm Abrader Mini Round Bur

Catalogue number 3530, listed by Suretek Medical, United States, under Accessories, Arthroscopic. 14 manufacturers in China are registered for this product code.

Power Cord for VS3 Cart – Brazil

Catalogue number VS3, listed by Visionsense, Ltd., United States, under Arthroscope. 21 manufacturers in China are registered for this product code.

Accessories, Arthroscopic

Arthroscopy-Sheath ‘Stryker’ 30°, With 2 Rotatable stopcocks,WL 92mm,

Arthroscopy-Sheath 'Stryker' 30°, with 2 rotatable stopcocks,WL 92mm, f.optics 4.0mm

Accessories, Arthroscopic

Intelijet

Obturator, Conical TIP, Fits ALL 6.0 MM Diagnostic Cannulas

Zavation

ZVplasty System Assembly

Accessories, Arthroscopic

Drill Guide, Curved, SureLock® 2.2mm

Catalogue number CM9625, listed by Cayenne Medical, Inc., United States, under Accessories, Arthroscopic. 14 manufacturers in China are registered for this product code.

Endoplastic Scope

Endoplastic Scope; 12''(33CM, )30 Degree, 10MM Diameter,

Accessories, Arthroscopic

ParallelPortal

Cannula with Zero Tube

Best Kit 22/16

2 catalogue numbers from US7OA2120, listed by Joline Gmbh & Co. KG, Germany, under Arthroscope. 21 manufacturers in China are registered for this product code.

Arthroscope

SINUSCOPE TROCAR SLEEVE, UNIVERSAL, FOR 3.0 MM SCOPES, 140 LENGTH, "0"d, "30"d, "70"d

Tube Set for Suction, 2-Lines, Single-Use

Catalogue number TS-P107-A, listed by W.O.M. World of Medicine GmbH, United States, under Arthroscope. 21 manufacturers in China are registered for this product code.

Accessories, Arthroscopic

Reprocessed 4.0mm Tricut Blade, Rotatable, Ext Length 13cm

Reprocessed 4mm Tricut Blade, Rotatable, Ext Length 13cm, without Tubing

Goniometer, Ac-Powered

Echo Secondary Inclinometer

Catalogue number 9RF304, listed by Jtech Medical, under Goniometer, Ac-Powered. 4 manufacturers in China are registered for this product code.

Dynamometer, Ac-Powered

ActivForce 2

Wireless digital dynamometer and goniometer.

FMS Nextra

FMS neXtra 2.9mm Mini Ultra-Affressive Cutter Shaver Blades

Doublefo

Smith + Nephew Pump/Shaver Interface Cable

Ectra

Ectra II Carpal Ligament System, Direct-View, 4.0 MM, 30 Degree, 100 Degree Working Length, Same Side Cannula Connection Service Replacement

Goniometer, Nonpowered

CanarE – Clinic Wearable Device

Catalogue number 43-5570-007-14, listed by Canary Medical USA LLC, United States, under Goniometer, Nonpowered. 14 manufacturers in China are registered for this product code.

Accessories, Arthroscopic

Endotrig

11 catalogue numbers from 1052, listed by Stryker GmbH, Switzerland, under Accessories, Arthroscopic. 14 manufacturers in China are registered for this product code.

Goniometer, Ac-Powered

E-Vive Nmes Electrode Set With Hook Backings

Catalogue number CY-1000-019, listed by Motive Health, Inc., United States, under Goniometer, Ac-Powered. 4 manufacturers in China are registered for this product code.

Goniometer, Nonpowered

Integra® Miltex®

Integra® Miltex® Polk Finger Goniometer, 5-3/4", Graduated in Inches and Centimeters

Kyphoplasty Balloon Catheter

Kyphoplasty Balloon Catheter from Jiangsu Changmei is an inflatable catheter for reducing fractures or creating a void in cancellous spinal bone during balloon kyphoplasty. It is used with…

Accessories, Arthroscopic

Endo – Misc

Extended HIP Grasper

Accessories, Arthroscopic

Reprocessed Hummer IV Aggressive Serrated Cutter

Reprocessed Hummer IV 3.5mm Aggressive Serrated Cutter, 8cm, Yellow

Accessories, Arthroscopic

Inion FreedomPin Instruments

Arthroscopic piston 2.0 mm

Stahl

Arthroscope HD + 4K; D = 1.9mm, l = 69mm, 30 degree, wide angle, autoclavable

Vertebra Biopsy Device Needle & Plunger

Catalogue number US9301, listed by Joline Gmbh & Co. KG, Germany, under Arthroscope. 21 manufacturers in China are registered for this product code.

T-FIX

T-FIX RCG Drill PAC, Sterile, With 1 Drill AND 2 Sleeves

Accessories, Arthroscopic

Tipcontrol

SPRING HANDLE without HF-connection, combinable with TipControl probe inserts, reusable

Accessories, Arthroscopic

Doublelatch

Doublelatch HIP Cannulated Obturator, 5.8 MM

Accessories, Arthroscopic

Quick-Connect

Single Stopcock Quick-Connect Bridge Adapter, 5.3MM ID

E9000

E9000, Tubing SET & TIP FOR E9010 High Speed Drill, With Irrigation

Accessories, Arthroscopic

TransPort

Transport Cannula 8MM Length 4, 5, 6

FMS

FMS Fluid Management System Outflow Tubing with One-way valve (FMS DUO Plus)

Dyonics Power

MTO Dyonics Power Swedish KIT 230-240V

InterV

13 Gauge 10mm Balloon Kyphoplasty Catheter (Micro)

Accessories, Arthroscopic

RZ Medizintechnik GmbH

Meniscus grasping forceps with ratchet 1x2 teeth, straight, 20cm

AccessVu 90

Disposable accessory kit to be used with IntraVu Scope 90. Kit contains 90mm cannula, 90mm trocar, cannula cap and stopcock.

Goniometer, Ac-Powered

DataLOG Management + Analysis Software (Version 10)

The Biometrics Analysis Software is a comprehensive tool for EMG, Goniometer and associated sensor analysis including real-time data analysis as the data is collected. The Analysis software…

Accessories, Arthroscopic

Lock-Stitch® Suture Passer

Catalogue number CM9010LS, listed by Cayenne Medical, Inc., United States, under Accessories, Arthroscopic. 14 manufacturers in China are registered for this product code.

Accessories, Arthroscopic

Reprocessed 4.0mm Rad 12 Curved Blade

Reprocessed 4mm Rad 12 Curved Blade

Accessories, Arthroscopic

Reprocessed 4.0mm Resector Cutter Blade

Catalogue number 375-542-000, listed by Suretek Medical, United States, under Accessories, Arthroscopic. 14 manufacturers in China are registered for this product code.

AnchorAccess Cobb Elevator, 19 Mm, Blade

Catalogue number PSZ-200-400, listed by Baylis Médicale Cie Inc, under Arthroscope. 21 manufacturers in China are registered for this product code.

SteriSpine VA

MEDINAUT Plus

Anchor Curved Tip Kerrison Rongeur

Catalogue number PSZ-400-201, listed by Baylis Médicale Cie Inc, under Arthroscope. 21 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