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.

Simple Locking Intramedullary (Slim) System

Slim Slap Hammer Assembly

Duraloc

Duraloc Polished Impactor

Impactor Tip (Curved)

Catalogue number 17340, listed by Biopro, Inc., United States, under Impactor. 18 manufacturers in China are registered for this product code.

Femoral Driver United Orthopedic

Catalogue number 9303-5710, listed by Enztec Limited, New Zealand, under Impactor. 18 manufacturers in China are registered for this product code.

Bengal

Bengal Stackable Cage System Cage Impactor

TriFit CF Hip System

Corin TriFit Stem Introducer w rounded tip

Enztec Classic OCI X – Corin

Catalogue number 4252-2320, listed by Enztec Limited, New Zealand, under Impactor. 18 manufacturers in China are registered for this product code.

Femur Impactor Head

Catalogue number 2115.00.400, listed by Total Joint Orthopedics, Inc., United States, under Impactor. 18 manufacturers in China are registered for this product code.

Romero Lateral Finishing Impactor XL

Catalogue number RO0002LFIX, listed by Spineup Inc, United States, under Impactor. 18 manufacturers in China are registered for this product code.

Polarcup Handle

Catalogue number 351342512005, listed by Enztec Limited, New Zealand, under Impactor. 18 manufacturers in China are registered for this product code.

GII

GII CR Femoral Impactor

Wombat

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

OCI X T-Handle Driver – S+N

Catalogue number 4252-2325, listed by Enztec Limited, New Zealand, under Impactor. 18 manufacturers in China are registered for this product code.

Precice® Intramedullary Limb Lengthening System Instrument

Orthopedic surgical instrument - for use with the intramedullary limb lengthening system

Mobis II

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

Gender Solutions® Natural-Knee®

Catalogue number 00-5413-020-03, listed by Zimmer, Inc., United States, under Impactor. 18 manufacturers in China are registered for this product code.

Femoral Head Impactor

Catalogue number 1305.00.000, listed by Total Joint Orthopedics, Inc., United States, under Impactor. 18 manufacturers in China are registered for this product code.

Offset Cup Impactor – M10x1 Interface

Catalogue number 02820019, listed by Incipio Devices, United States, under Impactor. 18 manufacturers in China are registered for this product code.

Femoral Hammer Sliding Impactor

Catalogue number 8200-45-000, listed by Biomet Orthopedics, United States, under Impactor. 18 manufacturers in China are registered for this product code.

Modulift

Modulift VBR SZ.L Footplate Remover

Alif

Alif Impactor-Crescent

Lospa Modular Knee System

Locking Rod Impactor

EcoFit® Stem Impactor Cross Hole

Catalogue number 30390109, listed by implantcast GmbH, Germany, under Impactor. 18 manufacturers in China are registered for this product code.

Alamo C

Impactor Instrument

Modular Knee Impactor Head, All-Poly

Catalogue number 2128.00.000, listed by Total Joint Orthopedics, Inc., United States, under Impactor. 18 manufacturers in China are registered for this product code.

Kgti™ Kinetik Great Toe Implant System

Metatarsal Impactor

Polarcup Impactor Interface Sz 45

Catalogue number 351342512145, listed by Enztec Limited, New Zealand, under Impactor. 18 manufacturers in China are registered for this product code.

Enztec Trinket M8x1.00-03

Catalogue number 4252-2373, listed by Enztec Limited, New Zealand, under Impactor. 18 manufacturers in China are registered for this product code.

Enztec Trinket M8x1.25-01

Catalogue number 4252-2368, listed by Enztec Limited, New Zealand, under Impactor. 18 manufacturers in China are registered for this product code.

Ustar II Knee System

Impactor base, distal femur

Mutars® Universal Impactor

Catalogue number 72100000, listed by implantcast GmbH, Germany, under Impactor. 18 manufacturers in China are registered for this product code.

Enztec XR Trinket M8X1.25-01

Catalogue number 4252-2444, listed by Enztec Limited, New Zealand, under Impactor. 18 manufacturers in China are registered for this product code.

Rabea

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

Universal Cone Impactor Head, Size 6, 24°

Cone Impactor Head, Size 6, 24 degrees

Enztec XR Trinket 5/16-24 UNF-02

Catalogue number 4252-2448, listed by Enztec Limited, New Zealand, under Impactor. 18 manufacturers in China are registered for this product code.

Romero Finishing Impactor

Catalogue number RO0027FIZZ, listed by Spineup Inc, United States, under Impactor. 18 manufacturers in China are registered for this product code.

Medacta Femoral Impactor Head

Catalogue number 4240-3072, listed by Enztec Limited, New Zealand, under Impactor. 18 manufacturers in China are registered for this product code.

Collet Style Inserter

Catalogue number SSI005970, listed by Zimmer, Inc., United States, under Impactor. 18 manufacturers in China are registered for this product code.

Enztec Trinket M10X1.00-01

Catalogue number 4252-2365, listed by Enztec Limited, New Zealand, under Impactor. 18 manufacturers in China are registered for this product code.

Offset Cup Impactor

Catalogue number MIH-004-00, listed by Enztec Limited, New Zealand, under Impactor. 18 manufacturers in China are registered for this product code.

CUP Impactor 4.0 Universal

Catalogue number H0034500099, listed by HPF SRL, under Impactor. 18 manufacturers in China are registered for this product code.

Accessory Conn. M10

Catalogue number H0034000329, listed by HPF SRL, under Impactor. 18 manufacturers in China are registered for this product code.

Spare TIP FOR CHS Impactor

Catalogue number 939999203, listed by Biomet Orthopedics, United States, under Impactor. 18 manufacturers in China are registered for this product code.

OCI Trinket X 3/8-24 UNF-02

Catalogue number 4252-2333, listed by Enztec Limited, New Zealand, under Impactor. 18 manufacturers in China are registered for this product code.

Femoral Impactor Head – S+N

Catalogue number 4240-3091, listed by Enztec Limited, New Zealand, under Impactor. 18 manufacturers in China are registered for this product code.

Lumbar Implant Holder

Lumbar Implant Holder Phenolic Handle (Disk Marker)

Alternate Bearing Liner Impactor

Catalogue number 31-131002, listed by Biomet Orthopedics, United States, under Impactor. 18 manufacturers in China are registered for this product code.

Agilon® XO Glenoid Inserter

Catalogue number 78010162, listed by implantcast GmbH, Germany, under Impactor. 18 manufacturers in China are registered for this product code.

Plate Impactor

Catalogue number 939999192, listed by Biomet Orthopedics, United States, under Impactor. 18 manufacturers in China are registered for this product code.

Enztec Straight Cup Impactor

Catalogue number 4252-2400, listed by Enztec Limited, New Zealand, under Impactor. 18 manufacturers in China are registered for this product code.

Enztec Femoral Impactor – Exactech

Catalogue number 02-029-19-1300, listed by Enztec Limited, New Zealand, under Impactor. 18 manufacturers in China are registered for this product code.

Kheiron

Axial connector impactor

Enztec Trinket 3/8-16 UNC-02

Catalogue number 4252-2358, listed by Enztec Limited, New Zealand, under Impactor. 18 manufacturers in China are registered for this product code.

TIB Impact PAD

Catalogue number SSI007561, listed by Zimmer, Inc., United States, under Impactor. 18 manufacturers in China are registered for this product code.

Bigliani Flatow

Catalogue number SSI005199, listed by Zimmer, Inc., United States, under Impactor. 18 manufacturers in China are registered for this product code.

NuGrip® CMC Implant System

Integra® NuGrip® The NuGrip Basal Thumb Impactor facilitates implant insertion and a tight fit.

Summa Orthopaedics System Surgical Instrument

Catalogue number SO-111-368, listed by Jeil Medical Corporation, South Korea, under Impactor. 18 manufacturers in China are registered for this product code.

Offset Cup Impactor – 3/8-16 Interface

Catalogue number 50341105, listed by Incipio Devices, United States, under Impactor. 18 manufacturers in China are registered for this product code.

ACS® Uni Femoral Impactor

Catalogue number 42160506, listed by implantcast GmbH, Germany, under Impactor. 18 manufacturers in China are registered for this product code.

K1 Hip Syetem

Unity Chamfer Block Impactor

Accessory Conn. M8x1

Catalogue number H0034000319, listed by HPF SRL, under Impactor. 18 manufacturers in China are registered for this product code.

Impactor

Impactor, Stem

All-Poly Tibial Impactor Head

Catalogue number 2220.00.000, listed by Total Joint Orthopedics, Inc., United States, under Impactor. 18 manufacturers in China are registered for this product code.

Modular Knee Impactor Head, Tibia

Tibial Impactor Head

Autobloquante

Catalogue number L85975, listed by Depuy (Ireland), Ireland, under Impactor. 18 manufacturers in China are registered for this product code.

Smith & Nephew 3/8 UNC CUP Impactor SN – CUP Impactor Pack

Catalogue number SN087100, listed by Symmetry Medical, United States, under Impactor. 18 manufacturers in China are registered for this product code.

Trochanteric Reattachment Device System (TRD)

Catalogue number 391.919, listed by Pioneer Surgical Technology, Inc., United States, under Impactor. 18 manufacturers in China are registered for this product code.

G7®

Catalogue number 110010765, listed by Biomet Orthopedics, United States, under Impactor. 18 manufacturers in China are registered for this product code.

IB3D™ PL Spinal System

Pusher A24000230 IB3D Implant Pusher

Hybrid® Glenoid Instrument

2 catalogue numbers from 406156, listed by Biomet Orthopedics, United States, under Impactor. 18 manufacturers in China are registered for this product code.

Pilling

Guarded Impactor, 7mm x 12.5mm, 8 1/2"

Enztec Classic OCI – Corin

Catalogue number 3991055, listed by Enztec Limited, New Zealand, under Impactor. 18 manufacturers in China are registered for this product code.

Offset Cup Impactor 5/16-24 UNF X 5

Catalogue number T18485, listed by MPS Micro Precision Systems AG, Switzerland, under Impactor. 18 manufacturers in China are registered for this product code.

Femur Extractor/Impactor

Catalogue number 2109.00.000, listed by Total Joint Orthopedics, Inc., United States, under Impactor. 18 manufacturers in China are registered for this product code.

Intermediate VHS Impactor

Catalogue number 35-463216, listed by Biomet Orthopedics, United States, under Impactor. 18 manufacturers in China are registered for this product code.

BIO-Modular Choice Porous

Catalogue number 406618, listed by Biomet Orthopedics, United States, under Impactor. 18 manufacturers in China are registered for this product code.

Impactor

2 catalogue numbers from 317-0015, listed by OsteoCentric Technologies,Inc, United States, under Impactor. 18 manufacturers in China are registered for this product code.

Enztec XR Trinket 3/8-24 UNF-04

Catalogue number 4252-2447, listed by Enztec Limited, New Zealand, under Impactor. 18 manufacturers in China are registered for this product code.

Ratcheting Handle

Catalogue number 18664, listed by Biopro, Inc., United States, under Impactor. 18 manufacturers in China are registered for this product code.

First Choice Modular Ulnar Head Implant

MUH Stem Impactor

Symmetry Bone

Symmetry® Packer, Bone Chip, 6.3 mm x 19 mm, 10 in

Impactor TIP

Catalogue number 324-0032, listed by OsteoCentric Technologies,Inc, United States, under Impactor. 18 manufacturers in China are registered for this product code.

Nexgen®

Catalogue number 00-5451-007-00, listed by Zimmer Trabecular Metal Technology, Inc., United States, under Impactor. 18 manufacturers in China are registered for this product code.

Allograft Wedge System

Allograft Wedge Impactor

Impactor

EcoFit® stem impactor guided M5

Enztec Trinket 7/16-20 UNF-01

Catalogue number 4252-2354, listed by Enztec Limited, New Zealand, under Impactor. 18 manufacturers in China are registered for this product code.

Tspace

Tspace Impactor Angled

InterPlate®

InterPlate®: 1 catalogue number listed by RSB Spine LLC., United States, under Impactor. 18 manufacturers in China are registered for this product code.

Polarcup

Polarcup Reducer Part FOR Impactor

Surgipros

Femoral Hread Driver

LMH

Catalogue number 62001010, listed by Wright Medical Technology, Inc., United States, under Impactor. 18 manufacturers in China are registered for this product code.

Romero Lateral Finishing Impactor

Catalogue number RO0028LFIZ, listed by Spineup Inc, United States, under Impactor. 18 manufacturers in China are registered for this product code.

Arcadius XP C

Arcadius XP C Impactor

Univation XM

Univation XM Tibial Impactor

Curved Acetabular Cup Impactor

Catalogue number 1213.00.000, listed by Total Joint Orthopedics, Inc., United States, under Impactor. 18 manufacturers in China are registered for this product code.

Agilon® Stem Impactor

Catalogue number 78010009, listed by implantcast GmbH, Germany, under Impactor. 18 manufacturers in China are registered for this product code.

Hook Tamp

Catalogue number 320-00-020, listed by Trilliant Surgical LLC, United States, under Impactor. 18 manufacturers in China are registered for this product code.

Impactor Tip (Straight)

Catalogue number 17387, listed by Biopro, Inc., United States, under Impactor. 18 manufacturers in China are registered for this product code.

Matisse Anterior Cervical Interbody Fusion Cage System

ACIF Cage Impactor

Vanguard® Premier™ Instruments

Catalogue number 32-486211, listed by Biomet Orthopedics, United States, under Impactor. 18 manufacturers in China are registered for this product code.

Rhead

Catalogue number 17-0956, listed by Stryker GmbH, Switzerland, under Impactor. 18 manufacturers in China are registered for this product code.

Journey II UNI

Tibia Free Impactor

CannuLink

Catalogue number IFS-060, listed by Tornier Inc., United States, under Impactor. 18 manufacturers in China are registered for this product code.

Free-Lock®

2 catalogue numbers from 1180-13, listed by Zimmer, Inc., United States, under Impactor. 18 manufacturers in China are registered for this product code.

Link Embrace Shoulder System Line Extension

Orthopaedic implant impactor - LINK Embrace Shoulder System

Vanguard Knee Instrumentation

Catalogue number 32-379661, listed by Biomet UK Ltd., United Kingdom, 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