Impactor

Who Makes This Device Type in China?

18 manufacturers in China hold an FDA registration for this device type, concentrated in Jiangsu, Shanghai and Beijing, and 3 other provinces. 7 of them are contract manufacturers, able to build to a buyer’s own specification.

Apex (Guangzhou) Tools & Orthopedics Company Guangdong, contract manufacturer
B-ONE Medical (Suzhou) Co., Ltd. Jiangsu, contract manufacturer
Beijing Fule Science & Technology Development Co., Ltd. Beijing
Beijing Rossumrobot Technology Co., Ltd. Beijing
Canwell Medical Co., Ltd. Zhejiang, contract manufacturer
Changzhou Geasure Medical Apparatus AND Instruments Co., Ltd. Jiangsu, contract manufacturer
Guangzhou Aquila Precise Tools Limited Guangdong, contract manufacturer
Johnson & Johnson Medical (Depuy – Suzhou) Ltd. Jiangsu
Medtronic (Changzhou) Medical Devices Technology Co., Ltd. Jiangsu
MicroPort Orthopedics Global Supply Center Limited Shanghai, contract manufacturer
Paragon Medical Device (Changzhou) Co., Ltd. Jiangsu, contract manufacturer
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai, contract manufacturer
Shanghai Reach Medical Instrument Co., Ltd. Shanghai
Suzhou Microport Orthorecon Co., Ltd. Jiangsu, contract manufacturer
Xinhua Healthcare Industry Co., Limited Shandong, contract manufacturer
Xinhua Surgical Instrument Co., Ltd. Shandong
Zhejiang Biomet Medical Products Co., Ltd. Zhejiang, contract manufacturer
Zimmer (Shanghai) Medical International Trading Co., Ltd. Shanghai

What Is FDA Product Code HWA?

Impactor is FDA product code HWA, 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 27 recalls under this product code since 2003. None was by a company in China. 2 are Class I, the most serious grade.

The root causes the FDA records most often are Device Design (10), Process design (3) and Nonconforming Material/Component (3). A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.

Enztec Classic OCI – Trinket M8x0.75-01

Catalogue number 4252-2087, listed by Enztec Limited, New Zealand, under Impactor. 18 manufacturers in China are registered for this product code.

Mobio™ Specialty

Femoral Impactor- Notch Type

Comprehensive

Catalogue number SSI004080, listed by Biomet Orthopedics, United States, under Impactor. 18 manufacturers in China are registered for this product code.

Offset Acetabular Shell Impactor Trinket – Enztec

Catalogue number 1080-0-1502, listed by Enztec Limited, New Zealand, under Impactor. 18 manufacturers in China are registered for this product code.

Enztec Trinket 3/8-24 UNF-02

Catalogue number 4252-2353, listed by Enztec Limited, New Zealand, under Impactor. 18 manufacturers in China are registered for this product code.

TJO – Universal Impactor Head

Catalogue number 2129.00.000, listed by Enztec Limited, New Zealand, under Impactor. 18 manufacturers in China are registered for this product code.

P.l.u.s.®

Clip Impactor

Tibial Impactor Head

Catalogue number 2115.00.200, listed by Total Joint Orthopedics, Inc., United States, under Impactor. 18 manufacturers in China are registered for this product code.

Semial

Catalogue number Graft loading platform, listed by Signus Medizintechnik Gmbh, Germany, under Impactor. 18 manufacturers in China are registered for this product code.

APR®

Catalogue number 9306-00-003, listed by Zimmer, Inc., United States, under Impactor. 18 manufacturers in China are registered for this product code.

Tecomet

Torque Limiting, Bi-Directional, Palm Impactor 3/16" Square Quick Lock, Cool Gray 7

Enztec Femoral Control Impactor / Extractor

Catalogue number 110031370, listed by Enztec Limited, New Zealand, under Impactor. 18 manufacturers in China are registered for this product code.

General Instrument

Posterior PC Tamp

ACS®

FB tibial impactor with silicon handle

Polaris 4.75 Deformity System

4.75 TI Hook Impactor

Juliet ® TI Instrumentation

Impactor Cap

LCS

LCS High Performance Instruments Femoral Impactor

Enztec Femoral Impactor – S+N

Catalogue number 4240-3092, listed by Enztec Limited, New Zealand, under Impactor. 18 manufacturers in China are registered for this product code.

Charlotte

Staple Impactor

Ortho Solutions Succession AFN System

Succession Impactor

T.l.i.f.

T.l.i.f. SG Instruments Bone Impactor, Straight

PediNail Intramedullary Platform

Impactor, Solid

U2 Total Knee System

PS Notch cutting jig impactor

Enztec Classic OCI – Corin Hex Driver

Catalogue number 3991055003, listed by Enztec Limited, New Zealand, under Impactor. 18 manufacturers in China are registered for this product code.

InTess C Cervical Cage System

Impactor Head, Modular, InTess C

Femoral Head Impactor, 204mm O/L

Catalogue number PN0283, listed by Platts & Nisbett Limited, under Impactor. 18 manufacturers in China are registered for this product code.

Solustaple®

The staple holder and impactor is used to handle and insert the SOLUS 90° staples.

Polarcup Impactor Interface Sz 59

Catalogue number 351342512159, listed by Enztec Limited, New Zealand, under Impactor. 18 manufacturers in China are registered for this product code.

NexGen® Trabucular Metal®

2 catalogue numbers from 00-5953-056-06, listed by Zimmer, Inc., United States, under Impactor. 18 manufacturers in China are registered for this product code.

Enztec Femoral Impactor With Slap Hammer – Narrow Head

Catalogue number 4240-3206, listed by Enztec Limited, New Zealand, under Impactor. 18 manufacturers in China are registered for this product code.

SSI Femoral Extractor Fork

Catalogue number SSI006620, listed by Zimmer, Inc., United States, under Impactor. 18 manufacturers in China are registered for this product code.

Universal Impactor Head

Catalogue number 2219.00.000, listed by Total Joint Orthopedics, Inc., United States, under Impactor. 18 manufacturers in China are registered for this product code.

Enztec Trinket 3/8-24 UNF-03

Catalogue number 4252-2370, listed by Enztec Limited, New Zealand, under Impactor. 18 manufacturers in China are registered for this product code.

Femur Extractor/Impactor Head

Catalogue number 2109.00.100, listed by Total Joint Orthopedics, Inc., United States, under Impactor. 18 manufacturers in China are registered for this product code.

Titan Reverse Shoulder System

Glenoid Baseplate Impactor MOD

Lospa Knee System

Box notch impactor

Int-Fix

Straight Shaft Impactor

Troch Grip Holder / Impactor

Catalogue number 498011, listed by Biomet Orthopedics, United States, under Impactor. 18 manufacturers in China are registered for this product code.

ANG TM Glenosphere Instr Handle

Catalogue number SSI006244, listed by Zimmer, Inc., United States, under Impactor. 18 manufacturers in China are registered for this product code.

Infinity™ Adaptis™

2 catalogue numbers from 9914PK02, listed by Wright Medical Technology, Inc., United States, under Impactor. 18 manufacturers in China are registered for this product code.

Romeo 2 Instrumentation

K Wire Impactor

Enztec Classic OCI – Corin Trinket

Catalogue number 3991055001, listed by Enztec Limited, New Zealand, under Impactor. 18 manufacturers in China are registered for this product code.

G7 High Offset Inserter

Catalogue number SSI006863, listed by Zimmer, Inc., United States, under Impactor. 18 manufacturers in China are registered for this product code.

Smith & Nephew Anteversion Guide – Offset CUP Impactor

Catalogue number 871002, listed by Symmetry Medical, United States, under Impactor. 18 manufacturers in China are registered for this product code.

Nubic

Catalogue number Graft loading platform, listed by Signus Medizintechnik Gmbh, Germany, under Impactor. 18 manufacturers in China are registered for this product code.

M2A 38MM Inserter Plate Multitool

Catalogue number 31-103810, listed by Biomet Orthopedics, United States, under Impactor. 18 manufacturers in China are registered for this product code.

Enztec Femoral Impactor With Slap Hammer

Catalogue number 4240-3200, listed by Enztec Limited, New Zealand, under Impactor. 18 manufacturers in China are registered for this product code.

Enztec Classic OCI – Trinket 7 /16-20 UNF-02

Catalogue number 4252-2099, listed by Enztec Limited, New Zealand, under Impactor. 18 manufacturers in China are registered for this product code.

Enztec Trinket 5/16-24 UNF-01

Catalogue number 4252-2367, listed by Enztec Limited, New Zealand, under Impactor. 18 manufacturers in China are registered for this product code.

Positioning Handle – 3/8-24 Interface

Accessory for Offset Cup Impactor

Curved Acetabular Cup Impactor – Ball Hex Driver

Catalogue number 1214.00.000, listed by Total Joint Orthopedics, Inc., United States, under Impactor. 18 manufacturers in China are registered for this product code.

Ashcom™ Shoulder

Catalogue number 01.04441.007, listed by Zimmer, Inc., United States, under Impactor. 18 manufacturers in China are registered for this product code.

CUP Impactor M8

2 catalogue numbers from H0031600099, listed by HPF SRL, under Impactor. 18 manufacturers in China are registered for this product code.

Mergence™-S

Catalogue number 96-106-30001, listed by Zimmer Trabecular Metal Technology, Inc., United States, under Impactor. 18 manufacturers in China are registered for this product code.

Orientable Alignment Guide – Supine 20°/45°

Alignment guide accessory of Offset Cup Impactor

Velofix™ PEEK Lumbar Cage

Catalogue number PLS0410, listed by CG MedTech Co., Ltd., South Korea, under Impactor. 18 manufacturers in China are registered for this product code.

Ascension®

Ascension® MCP Proximal impactor

Impactor

Insert Impaction Handle

CUP

Catalogue number APA05152, listed by Microport Orthopedics Inc., United States, under Impactor. 18 manufacturers in China are registered for this product code.

TJO – All Poly Impactor Head

Catalogue number 2128.00.000, listed by Enztec Limited, New Zealand, under Impactor. 18 manufacturers in China are registered for this product code.

Activ C

Activ C Impactor

MobileLink Acetabular Cup System – Instruments

3 catalogue numbers from 15-8385/01, listed by Waldemar Link GmbH & Co. KG, Germany, under Impactor. 18 manufacturers in China are registered for this product code.

Revision Knee System/TaperSet Hip System/Consensus Hip System/UniSyn Hip System

Femoral Head Impactor, UniSyn

Modular Knee Impactor Head, Universal

Catalogue number 2129.00.000, listed by Total Joint Orthopedics, Inc., United States, under Impactor. 18 manufacturers in China are registered for this product code.

Cespace

Cespace Bone Cort.-Cancellous Inserter

Subtalar Gen 2 QR Handle 3/16 Black

Catalogue number 22854, listed by Biopro, Inc., United States, under Impactor. 18 manufacturers in China are registered for this product code.

Reef

Catalogue number L93589, listed by Depuy (Ireland), Ireland, under Impactor. 18 manufacturers in China are registered for this product code.

Endoskeleton® TAS

Anterolateral Impactor

Enztec Classic OCI – Tornier Trinket

Catalogue number 3991077001, listed by Enztec Limited, New Zealand, under Impactor. 18 manufacturers in China are registered for this product code.

Enztec Femoral Head Impactor

Catalogue number 4250-2010, listed by Enztec Limited, New Zealand, under Impactor. 18 manufacturers in China are registered for this product code.

Vanguard Complete Knee Systemfemoral Inserter

Catalogue number 32-486206, listed by Biomet UK Ltd., United Kingdom, under Impactor. 18 manufacturers in China are registered for this product code.

Interseal®

2 catalogue numbers from 4820CI0000, listed by Microport Orthopedics Inc., United States, under Impactor. 18 manufacturers in China are registered for this product code.

Enztec XR Trinket 3/8-24 UNF-01

Catalogue number 4252-2443, listed by Enztec Limited, New Zealand, under Impactor. 18 manufacturers in China are registered for this product code.

Freedom Wrist Arthroplasty System

Carpal Plate Impactor

Enztec Trinket M10x1.50 – Truncated

Catalogue number 4252-2376, listed by Enztec Limited, New Zealand, under Impactor. 18 manufacturers in China are registered for this product code.

Cambria

Impactor, 7 in.

SL-Plus

SL/Geradschaft-Plus/CPS Head Impactor

Modular Radial Head (MRH) System

Impactor. Stem. MRH

Calix-C Cervical Interbody Spacer

Forceps Inserter, 13 x 16

OSS Small Impactor Assm

Catalogue number SSI000150, listed by Zimmer, Inc., United States, under Impactor. 18 manufacturers in China are registered for this product code.

Self Centering

Self Centering Modular Cathcart Handle Angled

Impactor for Cup Insert

2 catalogue numbers from 02820009, listed by implantcast GmbH, Germany, under Impactor. 18 manufacturers in China are registered for this product code.

Instrument

3 catalogue numbers from Graft impactor, listed by Signus Medizintechnik Gmbh, Germany, under Impactor. 18 manufacturers in China are registered for this product code.

Unity Knee System

Unity Knee Tibial Implant Introducer

Dynasty®

5 catalogue numbers from 33330040, listed by Microport Orthopedics Inc., United States, under Impactor. 18 manufacturers in China are registered for this product code.

Finn® Knee

2 catalogue numbers from 32-347906, listed by Biomet Orthopedics, United States, under Impactor. 18 manufacturers in China are registered for this product code.

Enztec Femoral Impactor – Corin W Handle

Catalogue number 4240-3089, listed by Enztec Limited, New Zealand, under Impactor. 18 manufacturers in China are registered for this product code.

Enztec Classic OCI – Trinket 3/8-24 UNF-01

Catalogue number 4252-2090, listed by Enztec Limited, New Zealand, under Impactor. 18 manufacturers in China are registered for this product code.

Versa Dial(TM) Shoulder System

Catalogue number 407297, listed by Biomet Orthopedics, United States, under Impactor. 18 manufacturers in China are registered for this product code.

Pyxis 3d Titanium Cervical Cage, Close

3D Cervical Cage Impactor

Trigen MAX

Trigen MAX Medium Cannulated Impactor

Attune Femoral Impactor Head

Catalogue number 254800003, listed by Enztec Limited, New Zealand, under Impactor. 18 manufacturers in China are registered for this product code.

CHS

Catalogue number 71176714, listed by Smith & Nephew, Inc., United States, under Impactor. 18 manufacturers in China are registered for this product code.

EcoFit® Coupled Impactor

Catalogue number 30390115, listed by implantcast GmbH, Germany, under Impactor. 18 manufacturers in China are registered for this product code.

Endoskeleton® TA

Catalogue number 2106-1000, listed by Medtronic Sofamor Danek, Inc., United States, under Impactor. 18 manufacturers in China are registered for this product code.

UCP™ Stem

UCP Cement restrictor inserter

Mobio™ Total Knee System

Tibial Baseplate Impactor

Enztec Trinket M8X1.00-01

Catalogue number 4252-2364, listed by Enztec Limited, New Zealand, under Impactor. 18 manufacturers in China are registered for this product code.

Offset Saddle Impactor

Catalogue number 430084, listed by Biomet Orthopedics, United States, under Impactor. 18 manufacturers in China are registered for this product code.

Enztec OCI Collet – 3/8-16 UNC-01

Catalogue number 4252-2028, listed by Enztec Limited, New Zealand, under Impactor. 18 manufacturers in China are registered for this product code.

HP Femoral Imp/Ext W/O Handle

Catalogue number 950501171, listed by Enztec Limited, New Zealand, under Impactor. 18 manufacturers in China are registered for this product code.

Integra™Allograft Wedge System

Integra™Allograft Wedge System Impactor

Agilon® Impactor Screw Trauma

Catalogue number 78010124, listed by implantcast GmbH, Germany, under Impactor. 18 manufacturers in China are registered for this product code.

Allograft – Cortical,construx – Mini Peek VBR

Catalogue number 30-1030, listed by Orthofix US LLC, United States, under Impactor. 18 manufacturers in China are registered for this product code.

Enztec Femoral Impactor – Corin

Catalogue number 1232147, listed by Enztec Limited, New Zealand, under Impactor. 18 manufacturers in China are registered for this product code.

Global Advantage

Global Advantage Anti Rotation PIN Grasper

Salto Talaris®

Talar component impactor

A-Space Sibd

Catalogue number SJ606R, listed by Aesculap AG, Germany, under Impactor. 18 manufacturers in China are registered for this product code.

Guiding Handle

Catalogue number 18650, listed by Biopro, Inc., United States, under Impactor. 18 manufacturers in China are registered for this product code.

Enztec Trinket M10x0.75-01

Catalogue number 4252-2356, listed by Enztec Limited, New Zealand, under Impactor. 18 manufacturers in China are registered for this product code.

OSS™ Orthopedic Salvage System / Arcos®

Catalogue number 110027910, listed by Biomet Orthopedics, United States, under Impactor. 18 manufacturers in China are registered for this product code.

Barrel / Plate Impactor

Catalogue number 456426, listed by Biomet Orthopedics, United States, under Impactor. 18 manufacturers in China are registered for this product code.

Titan Humeral Resurfacing Arthroplasty

HRA Impactor

Link Embrace Shoulder System – Instruments

Orthopaedic implant impactor - LINK Embrace Shoulder System

Corentec Femoral Impactor Head

Catalogue number 4240-3103, listed by Enztec Limited, New Zealand, under Impactor. 18 manufacturers in China are registered for this product code.

Global Spinal Fixation System™

Catalogue number SG0019, listed by CG MedTech Co., Ltd., South Korea, under Impactor. 18 manufacturers in China are registered for this product code.

Reflection

NON-Threaded CUP Impactor

Impactor

Poly Liner Impactor, 28mm

Intervertebral Body Fusion Device

Impactor Curved Serrated 20mm

V-TIP Disimpactor

Catalogue number SSI001457, listed by Zimmer, Inc., United States, under Impactor. 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