Mixer, Cement, for Clinical Use

Which Manufacturers in China Make This?

Chinese manufacturers registered for this device type are concentrated in Guangdong, Beijing and Hebei, and 4 other provinces: 14 hold an FDA registration. 2 are contract manufacturers.

Beijing Zksk Technology Co., Ltd. Beijing, contract manufacturer
CDM Center OF Excellence Ltd. Beijing
Debo Medical Technology (Shijiazhuang) Co., Ltd. Hebei, contract manufacturer
Dongguan Kaiser Technology Co., Ltd. Guangdong, contract manufacturer
Guangzhou Clean Medical Products Manufacturing Corp Guangdong, contract manufacturer
Hubei Guarddent Medical Technology Co., Ltd. Hubei
Huizhou Videya Technology Co., Ltd. Guangdong
JIE GAO Plastic Products Co., Ltd. Guangdong, contract manufacturer
Ningbo Hicren Biotechnology Co., Ltd. Zhejiang
Premium Plus (Dongguan) Limited Guangdong
Shanghai Hua En Industrial Co Ltd Shanghai, contract manufacturer
Suzhou Pac-Dent Technology Co., Ltd. Jiangsu, contract manufacturer
Tangshan Zhengtong Exhibition Co., Ltd. Hebei
Zimmer (Shanghai) Medical International Trading Co., Ltd. Shanghai

How Is JDZ Classified?

Mixer, Cement, For Clinical Use is FDA product code JDZ, Class 1, 21 CFR 888.4210.

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 Has Gone Wrong With It?

The FDA has recorded 18 recalls under this product code since 2008. None was by a company in China. The root causes the FDA records most often are Environmental control (6), Labeling Change Control (4) and Nonconforming Material/Component (2).

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

Mixer, Cement, For Clinical Use

Howmedica, Definition

Femoral Pressuring Seal Size 1-4

Mixer, Cement, For Clinical Use

AutoPlex M4

M4 Cement Mixer

Mixer, Cement, For Clinical Use

CMM1

Catalogue number G90004, listed by IZI Medical Products LLC, United States, under Mixer, Cement, For Clinical Use. 14 manufacturers in China are registered for this product code.

Mixer, Cement, For Clinical Use

Mixing Bowl

Bone Cement Mixing System

Mixer, Cement, For Clinical Use

PCD, VertaPlex

Precision System Kit with Short Extension Tube and HV Bone Cement

Mixer, Cement, For Clinical Use

Osteogun

Catalogue number VCF-1020, listed by Teknimed SAS, France, under Mixer, Cement, For Clinical Use. 14 manufacturers in China are registered for this product code.

Mixer, Cement, For Clinical Use

Bowl AND Spatula

Bowl and Spatula are accessories intended for bone cement mixing.

Mixer, Cement, For Clinical Use

PicoMix V

Mixing System and Delivery Syringes

Mixer, Cement, For Clinical Use

MixEvac

3 Bone Cement Mixer with Small Spatula

Mixer, Cement, For Clinical Use

HiVac™ Bowl Bone Cement Mixing System

Catalogue number B713, listed by Summit Medical LLC, United States, under Mixer, Cement, For Clinical Use. 14 manufacturers in China are registered for this product code.

Mixer, Cement, For Clinical Use

ManuMix

ManuMix® is a mixing system for bone cements of low to medium viscosity and subsequent transfer in syringes for clinical application.

Mixer, Cement, For Clinical Use

Palabowl

Bone Cement Mixing System (Logo: PALABOWL)[Model No.:CL006-01)

Mixer, Cement, For Clinical Use

HiVac Bowl

Catalogue number B713, listed by Summit Medical LLC, United States, under Mixer, Cement, For Clinical Use. 14 manufacturers in China are registered for this product code.

Mixer, Cement, For Clinical Use

Cemex System Container

Cemex System Container is a container for Tecres' Cemex System that allows the mixing of Cemex System bone cement into Tecres' Cemex System Mixer.

Mixer, Cement, For Clinical Use

Disp. Mixing Bowl-O

Open Mixing System FOR Bone Cement Preparation

Mixer, Cement, For Clinical Use

Easymix® Bowl

EASYMIX® bowl, Bone Cement Mixing System

Mixer, Cement, For Clinical Use

Zavation

Vertebroplasty/Kyphoplasty Mixing Cement System

Mixer, Cement, For Clinical Use

SmartMix™ CTS Vacuum Mixing Bowl

Vacuum Mixing Bowl

Mixer, Cement, For Clinical Use

Summit Medical

Vacuum Cement Mixing Bowl

Mixer, Cement, For Clinical Use

PCD

Precision System without Needle

Mixer, Cement, For Clinical Use

Heraeus

Bone Cement Mixing System Accessory: Trumpet Adapter[Model No.:CL006-01]

Mixer, Cement, For Clinical Use

Arthrex Bone Cement Open Mixing Bowl

Catalogue number AR-901-1, listed by G21 SRL, under Mixer, Cement, For Clinical Use. 14 manufacturers in China are registered for this product code.

Mixer, Cement, For Clinical Use

MectaCem Bowl

Catalogue number 20.00004, listed by Tecres SPA, Italy, under Mixer, Cement, For Clinical Use. 14 manufacturers in China are registered for this product code.

Mixer, Cement, For Clinical Use

Optivac Kit, 120 Gram Triple Mix

2 catalogue numbers from 418300, listed by Biomet, Inc., United States, under Mixer, Cement, For Clinical Use. 14 manufacturers in China are registered for this product code.

Mixer, Cement, For Clinical Use

Easymix® Nozzle Slim

The vacuum mixing systems EASYMIX® is a mixing systems for PMMA bone cements, which are indicated to be used with a mixing system. The mixing system is composed of the mixing cartridge with…

Mixer, Cement, For Clinical Use

Mixing Wells

Disposable. 2-well configuration (480/box)

Mixer, Cement, For Clinical Use

Power-Flo®

2 catalogue numbers from 00-5049-045-01, listed by Zimmer Orthopaedic Surgical Products, United States, under Mixer, Cement, For Clinical Use. 14 manufacturers in China are registered for this product code.

Mixer, Cement, For Clinical Use

Easymix Pro

Vacuum mixing system for mixing of PMMA bone cements

Mixer, Cement, For Clinical Use

MiniMix™ Bone Cement/Substitute Mixing System

Bone Cement/Substitute Mixing System

Mixer, Cement, For Clinical Use

ACM

Bowl with High Vacuum Blades and Cement Cartridge with Breakaway Femoral Nozzle

Mixer, Cement, For Clinical Use

MiniMix™

Catalogue number SMMM1, listed by Summit Medical LLC, United States, under Mixer, Cement, For Clinical Use. 14 manufacturers in China are registered for this product code.

Mixer, Cement, For Clinical Use

OptiTwist®

Vacuum Mixing Bowl

Mixer, Cement, For Clinical Use

MixEvac, ACM

3 Bone Cement Mixer with Spatula

Mixer, Cement, For Clinical Use

QuattroMix

Catalogue number US9620, listed by Joline Gmbh & Co. KG, Germany, under Mixer, Cement, For Clinical Use. 14 manufacturers in China are registered for this product code.

Mixer, Cement, For Clinical Use

Easymix® Nozzle Revision

The vacuum mixing systems EASYMIX® is a mixing systems for PMMA bone cements, which are indicated to be used with a mixing system. The mixing system is composed of the mixing cartridge with…

Mixer, Cement, For Clinical Use

Mixer, Cement, for Clinical Use

Catalogue number 5049-11, listed by Zimmer, Inc., United States, under Mixer, Cement, For Clinical Use. 14 manufacturers in China are registered for this product code.

Mixer, Cement, For Clinical Use

Mixing System Adapted to High Viscosity Injection System

Catalogue number T060420, listed by Teknimed SAS, France, under Mixer, Cement, For Clinical Use. 14 manufacturers in China are registered for this product code.

Mixer, Cement, For Clinical Use

Biopsybell

Vertebroplasty / Kyphoplasty cement mixing system

Mixer, Cement, For Clinical Use

S5M

Catalogue number T060407, listed by Teknimed SAS, France, under Mixer, Cement, For Clinical Use. 14 manufacturers in China are registered for this product code.

Mixer, Cement, For Clinical Use

Arthrex Bone Cement Mixing Syringe

2 catalogue numbers from AS-901-3, listed by G21 SRL, under Mixer, Cement, For Clinical Use. 14 manufacturers in China are registered for this product code.

Mixer, Cement, For Clinical Use

Easy KIT

Catalogue number T060409, listed by Teknimed SAS, France, under Mixer, Cement, For Clinical Use. 14 manufacturers in China are registered for this product code.

Mixer, Cement, For Clinical Use

AutoPlex

System without Needles and Cement

Mixer, Cement, For Clinical Use

Vortex

Vortex Vacuum Mixing System

Mixer, Cement, For Clinical Use

Easy KIT M

Catalogue number T060415, listed by Teknimed SAS, France, under Mixer, Cement, For Clinical Use. 14 manufacturers in China are registered for this product code.

Mixer, Cement, For Clinical Use

Mixor

MIX-OR Vacuum Pump Connector - Drager

Mixer, Cement, For Clinical Use

Palamix®

PALAMIX® is a vacuum mixing and application system for bone cements. It consists of: –PALAMIX® uno or PALAMIX® duo vacuum mixing system PALAMIX® uno and PALAMIX® duo allow for automatic…

Mixer, Cement, For Clinical Use

MARK3

Dappen Dish Glass Clear 12/bx. - MARK3®*

Mixer, Cement, For Clinical Use

MiniMix™ LV

Bone Cement Mixing System

Mixer, Cement, For Clinical Use

Zksk

Disposable Bone Cement Vacuum Mixing System

Mixer, Cement, For Clinical Use

Mixing Bowl, Spatula

3 catalogue numbers from B710, listed by Summit Medical LLC, United States, under Mixer, Cement, For Clinical Use. 14 manufacturers in China are registered for this product code.

Mixer, Cement, For Clinical Use

Medline Industries, Inc.

Bowl Mixing Bone Cement KIT 3

Mixer, Cement, For Clinical Use

Mixer, Cement, for Clinical Use

Mixer A07A Cement

Mixer, Cement, For Clinical Use

Shakit

Shakit is intended for mixing acrylic resins or bone void fillers components.

Mixer, Cement, For Clinical Use

Osseofix

Catalogue number 21302, listed by Teknimed SAS, France, under Mixer, Cement, For Clinical Use. 14 manufacturers in China are registered for this product code.

Mixer, Cement, For Clinical Use

Clean

Catalogue number CL006-01BE, listed by Guangzhou Clean Medical Products Manufacturing Corp, China, under Mixer, Cement, For Clinical Use. 14 manufacturers in China are registered for this product code.

Mixer, Cement, For Clinical Use

Optivac Kit, 80 Gram Double Mix

2 catalogue numbers from 417200, listed by Biomet, Inc., United States, under Mixer, Cement, For Clinical Use. 14 manufacturers in China are registered for this product code.

Mixer, Cement, For Clinical Use

Optivac Fusion

Catalogue number 419000, listed by Biomet, Inc., United States, under Mixer, Cement, For Clinical Use. 14 manufacturers in China are registered for this product code.

Mixer, Cement, For Clinical Use

ZVplasty Cement Mixer Kit

Catalogue number VCF-1016, listed by Teknimed SAS, France, under Mixer, Cement, For Clinical Use. 14 manufacturers in China are registered for this product code.

Mixer, Cement, For Clinical Use

Mixer

Catalogue number US9610, listed by Joline Gmbh & Co. KG, Germany, under Mixer, Cement, For Clinical Use. 14 manufacturers in China are registered for this product code.

Mixer, Cement, For Clinical Use

PicoMix Bowl

Bone Cement Closed Mixing System

Mixer, Cement, For Clinical Use

Rally™ Vacuum Mixing Bowl

2 catalogue numbers from 7127-1801, listed by Summit Medical LLC, United States, under Mixer, Cement, For Clinical Use. 14 manufacturers in China are registered for this product code.

Mixer, Cement, For Clinical Use

CMM4

Catalogue number G37374, listed by IZI Medical Products LLC, United States, under Mixer, Cement, For Clinical Use. 14 manufacturers in China are registered for this product code.

Mixer, Cement, For Clinical Use

Premium Plus

Disposable Dynamic Mixing Tips

Mixer, Cement, For Clinical Use

Revolution, ACM

Cement Mixing System with Femoral Breakaway Nozzle, Advanced Femoral Canal Pressurizer (Medium) and Spatula

Mixer, Cement, For Clinical Use

Minimalax

Catalogue number T060406, listed by Teknimed SAS, France, under Mixer, Cement, For Clinical Use. 14 manufacturers in China are registered for this product code.

Mixer, Cement, For Clinical Use

PicoMix Syringe

Bone Cement Mixing System (120 gr)

Mixer, Cement, For Clinical Use

Quick-Vac® Vacuum Mixing Bowl

4 catalogue numbers from 00504900100, listed by Summit Medical LLC, United States, under Mixer, Cement, For Clinical Use. 14 manufacturers in China are registered for this product code.

Mixer, Cement, For Clinical Use

Darby Dental Supply, LLC

Tmix Core Xfine IO TIP Brown

Mixer, Cement, For Clinical Use

2mix

2Mix is a medical device for mixing bone cement. The device includes several components: mixing container, mixing cap, cannula, pusher-rod and vacuum tube. 2Mix is supplied sterile, for…

Mixer, Cement, For Clinical Use

Vacuum Cement Mixing Bowl

Catalogue number 1400-2100, listed by Summit Medical LLC, United States, under Mixer, Cement, For Clinical Use. 14 manufacturers in China are registered for this product code.

Mixer, Cement, For Clinical Use

Smartset

Smartset GHV GENTAMICIN High Viscosity Bone Cement 40g

Mixer, Cement, For Clinical Use

Henry Schein

Pentamix Dynamic Mixing Tips, Orange, 50 pcs/pk

Mixer, Cement, For Clinical Use

Arthrex Bone Cement Closed Mixing Bowl

2 catalogue numbers from AS-901-2, listed by G21 SRL, under Mixer, Cement, For Clinical Use. 14 manufacturers in China are registered for this product code.

Mixer, Cement, For Clinical Use

Revolution

Cement Mixing System with Femoral Breakaway Nozzle, Medium Solid Proximal Pressurizer, Universal Cement Restrictor with Disposable Inserter and Small Cement Restrictor

Mixer, Cement, For Clinical Use

AutoPlex, VertaPlex

M4 Cement Mixer for Manifold with HV Bone Cement

Mixer, Cement, For Clinical Use

Optivac Total Hip Kit

2 catalogue numbers from 417000, listed by Biomet, Inc., United States, under Mixer, Cement, For Clinical Use. 14 manufacturers in China are registered for this product code.

Mixer, Cement, For Clinical Use

Max V Cement Mixing System

Catalogue number NuVasive Cement Mixing System, listed by Teknimed SAS, France, under Mixer, Cement, For Clinical Use. 14 manufacturers in China are registered for this product code.

Mixer, Cement, For Clinical Use

Midway Select

Midway Select T-Mixer HP Mixing Tips Green/Teal (48)

Mixer, Cement, For Clinical Use

Mini-Bowls

Non-stick silicone for acrylics, with suction base. Medium, 30 cc (Set of 2) (1 5/8” diameter)

Mixer, Cement, For Clinical Use

Mixer, Cement, for Clinical Use

Femoral Canal Pressurizer without Hub, Medium

Mixer, Cement, For Clinical Use

Mixer, Cement, for Clinical Use

Cement KIT FOR Pegged Glenoid

Mixer, Cement, For Clinical Use

Optivac Kit, 40 Gram Single Mix

Catalogue number 417100, listed by Biomet, Inc., United States, under Mixer, Cement, For Clinical Use. 14 manufacturers in China are registered for this product code.

Mixer, Cement, For Clinical Use

Cleanest

Bone Cement Mixing System(Vacuum hose with trumpet adapter)

Mixer, Cement, For Clinical Use

DJO Surgical

Optivac MAX Capacity Total HIP KIT (High VOL Cement)

Mixer, Cement, For Clinical Use

Premium Plus

Disposable dynamic mixing tips

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