Instrument, Surgical, Orthopedic, Dc-Powered Motor and Accessory/Attachment

Who Makes This Device Type in China?

Chinese manufacturers registered for this device type are concentrated in Jiangsu, Guangdong and Hunan, and 4 other provinces: 10 hold an FDA registration. 3 are contract manufacturers.

Apex (Guangzhou) Tools & Orthopedics Company Guangdong, contract manufacturer
Denjoy Dental Co., Ltd. Hunan, contract manufacturer
Gavin Biotechnology Co., Ltd. Shanxi
Huzhou Junda Industry Co., Ltd. Zhejiang, contract manufacturer
Jiangsu Saikang Medical Equipment Co., Ltd. Jiangsu, contract manufacturer
Jiangsu Yongfa Medical Equipment Technology Co., Ltd. Jiangsu
Paragon Medical Device (Changzhou) Co., Ltd. Jiangsu, contract manufacturer
Shaanxi Ansen Medical Technology Development Co., Ltd. Shaanxi, contract manufacturer
Shanghai NO. 2 Medical College Duhang Medical Equipment Factory Shanghai, contract manufacturer
Suzhou Number WIN Medical Technology Co., Ltd. Jiangsu

How Is KIJ Classified?

Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment is FDA product code KIJ, 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 10 recalls under this product code since 2008. None was by a company in China. The root cause the FDA records most often is Component design/selection (10).

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

Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment

SSG20

Charger

Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment

Medinaut MAX Pro

MEDINAUT MAX Pro handpiece

Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment

Global Icon

GLOBAL ICON Stemless Shoulder System CENTRAL DRILL

Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment

Minidriver Solaris

Catalogue number Minidriver Solaris, listed by GM DOS Reis Industria E Comercio Ltda, Brazil, under Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment. 10 manufacturers in China are registered for this product code.

Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment

Clearfix Rigid Sternal Fixation Power Driver

2 catalogue numbers from CF-111-ED-051, listed by Jeil Medical Corporation, South Korea, under Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment. 10 manufacturers in China are registered for this product code.

Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment

Valkyrie® – Power Driver

Catalogue number 01-03-3035, listed by Jeil Medical Corporation, South Korea, under Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment. 10 manufacturers in China are registered for this product code.

Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment

Global CAP

Global CAP Humeral Head Shaper Handle

Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment

3p Small-Mini Frag System

2.7/3.5 Torque Limiter Coupling, AO, 2.0Nm

Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment

Neuro Plating System

Catalogue number IOC-141, listed by Osteonic Co., Ltd., South Korea, under Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment. 10 manufacturers in China are registered for this product code.

Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment

Neuro & Craniofacial Fixation System

Sterilized Electric Screw Driver, Cranial, Plastic, electronics, SST

Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment

Consensus Knee System

Stop Drill, Pegless Knee

Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment

FiberLocker PowerUnit – Handpiece

Catalogue number PU7050A1, listed by Zurimed Technologies AG, Switzerland, under Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment. 10 manufacturers in China are registered for this product code.

Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment

Delta Xtendtm

Delta Xtendtm Make TO Order Locking AO Screwdriver Shaft

Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment

UniSyn Hip System

22mm Cone Reamer, UniSyn

Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment

FiberLocker PowerUnit – Motor Pack

Catalogue number PU7050A2, listed by Zurimed Technologies AG, Switzerland, under Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment. 10 manufacturers in China are registered for this product code.

Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment

OptiMesh Multiplanar Expandable Interbody Fusion System

Powered Straight Brush

Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment

Revision Knee System

RKS, Stop Drill Bit, .25 OD x .50 Dp, SS

Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment

Sterile Drill Bit

Single-Use, Non-cannulated Drill, Sterile

Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment

Lospa Knee System, Exult Knee System

Catalogue number KZ.020.0007, listed by Corentec Co., Ltd., South Korea, under Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment. 10 manufacturers in China are registered for this product code.

Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment

Inlet System Surgical Instrument

Catalogue number IN111-ED-051, listed by Jeil Medical Corporation, South Korea, under Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment. 10 manufacturers in China are registered for this product code.

Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment

Valkyrie® RIB – Power Driver

Catalogue number 05-03-2528, listed by Jeil Medical Corporation, South Korea, under Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment. 10 manufacturers in China are registered for this product code.

Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment

Bencox Surgical Instruments

Reamer handle

Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment

Exult Knee Replacement System Instrument

Catalogue number KA.SPD.0001, listed by Corentec Co., Ltd., South Korea, under Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment. 10 manufacturers in China are registered for this product code.

Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment

Response 5.5/6.0

Response 5.5/6.0 Initial Set Screw Driver, Short

Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment

Traus SSG20

G100+C100+P100+ASC10

Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment

TD-Auto

BEW10+MCE30NN+CRB19NN

Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment

FiberLocker PowerUnit – Charging Station

Catalogue number PU7050A3, listed by Zurimed Technologies AG, Switzerland, under Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment. 10 manufacturers in China are registered for this product code.

Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment

EZImpactor

EZImpactor(Stryker Type Broach Adapter_Extra Offset)

Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment

CS2 Acetabular System

Drill, Bayonet, 3.2mm, 45mm

Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment

Instrument, Surgical, Orthopedic, Dc-Powered Motor and Accessory/Attachment

High Torque Drill with Chuck 2:1 with Key

Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment

SSG40

Shield cover

Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment

Level ONE

Handle, Screwdriver, Battery Operated, W/OUT Battery Pack, Increased Torque

Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment

Mabis

Palm Aneroid Gauge

Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment

Smarto

4 catalogue numbers from 111-ED-030, listed by Jeil Medical Corporation, South Korea, under Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment. 10 manufacturers in China are registered for this product code.

Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment

Response 4.5/5.0, 5.5/6.0

Power Attachment, 6.35mm (1/4 in) Drive

Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment

OrthoPediatrics Hardware Removal

Driver, Cannulated 5.0mm Hex

Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment

DynaPower

2 catalogue numbers from DMP-7000M, listed by DynaMedic Co., Ltd., South Korea, under Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment. 10 manufacturers in China are registered for this product code.

Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment

PNP Tibia

6.0mm MONOBLOC NITINOL REAMER, 435mm

Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment

Delta Xtend

DELTA XTEND Central Screw Metaglene augmented metaglene reamer inner drive shaft tip

Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment

Lospa Surgical Instruments

Femoral Condyle Drill

Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment

Lospa Knee System

Catalogue number KA.SPC.0002, listed by Corentec Co., Ltd., South Korea, under Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment. 10 manufacturers in China are registered for this product code.

Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment

Inhance

Inhance Shoulder System ONE Step Prep Glenoid Reamer – Circular X- Small

Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment

Global Steptech

Global Steptech Anchor PEG Glenoid Steptech Oscl Rasp LG +3 Linv Fits: Conmed Microfree AND Hall Micropower Large +3MM

Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment

Inhance Shoulder System

Inhance Shoulder System Glenoid Prep KIT Medium NA

Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment

Hudson

3.25:1 / Modified Trinkle

Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment

Bencox

Offset Reamer Handle

Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment

R&D Batteries, Inc.

9.6 Volt .65Ah NiCd-Stryker Insert

Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment

Medinaut MAX

MEDINAUT MAX Drill Universal Type Attachment

Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment

3p Hip System

2.4mm x 250mm Threaded Guide Wire

Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment

FiberLocker PowerUnit – Transfer Shield

Catalogue number PU7050A4, listed by Zurimed Technologies AG, Switzerland, under Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment. 10 manufacturers in China are registered for this product code.

Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment

Inhance Intact

INHANCE INTACT HUMERAL REAMER X-LARGE Ø44mm

Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment

MicroAire®

Wire Driver, Cannulated, Microaire Connector

Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment

Sterile Drill Bit – RMR

Single-Use, Non-cannulated Drill, Sterile

Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment

AO

3.25:1 Large Reamer

Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment

Response Spine System

5.5/6.0 Power CANNULATED Pedicle Reduction Screw Driver, 140MM

Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment

Endo Motor

6 catalogue numbers from iMate 3, listed by Denjoy Dental Co., Ltd., China, under Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment. 10 manufacturers in China are registered for this product code.

Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment

Traus

K-WIRE, ø2.7~3.2mm

Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment

Acumed

12mm BGH 2 Kit

Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment

Pediatric Nailing Platform | Tibia

Tapered Screw Driver, 4.0 Hex, Short, ZH QC

Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment

OsteoMed

OsteoDriver2, Disposable Battery Powered Screwdriver, Sterile

Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment

Insurgical, Inc.

Reciprocating Saw Packaged Assembly

Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment

Instrument, Surgical, Orthopedic, Dc-Powered Motor and Accessory/Attachment

SOD 2.9MM Cannula W/DL Inflw

Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment

Tahoe Unicompartmental Knee System

TUKS, Femoral IM Starter Drill, 4.8mm X 203mm

Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment

Stainless Steel Guide Wires

2.0/2.8mm x 110 SS Wire 20mm Partial Thread

Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment

Traus SSG40

C200/G200/P200/ASC20

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