Brasseler EZX Blade

29 catalogue numbers from BRXTB590, listed by Imedicom Co., Ltd., South Korea, under Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment. 23 manufacturers in China are registered for this product code.

Registry build 21.09.26
23manufacturers in China registered for this device type
29catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (8), Shanghai (6), Guangdong (3). 11 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code HWE
Manufacturer City Province Registered as Device types
Apex (Guangzhou) Tools & Orthopedics Company Guangzhou Guangdong Contract manufacturer 62
Paragon Medical Device (Changzhou) Co., Ltd. Changzhou Jiangsu Contract manufacturer 53
Canwell Medical Co., Ltd. Jinhua Zhejiang Contract manufacturer 42
Suzhou Microport Orthorecon Co., Ltd. Suzhou Jiangsu Contract manufacturer 31
Jabil Circuit (Shanghai) Ltd. Shanghai Shanghai Contract manufacturer 31
Guangzhou Aquila Precise Tools Limited Guangzhou Guangdong Contract manufacturer 28
Dongguan BAO Kang Dian ZI KE JI Limited Dongguan Guangdong Contract manufacturer 24
Stryker (Suzhou) Medical Technology Co., Ltd. Suzhou Jiangsu Contract manufacturer 19
Suzhou Ahno Medical Devices Co., Ltd. Suzhou Jiangsu Contract manufacturer 17
Autocam Medical Devices (Suzhou) Co., Ltd. Suzhou Jiangsu Contract manufacturer 9
Shaanxi Ansen Medical Technology Development Co., Ltd. Xi’An Shaanxi Contract manufacturer 7
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai Shanghai Contract manufacturer 235

Showing 12 of 23. All 23 manufacturers in China registered for Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment

Record

Regulatory record for Brasseler EZX Blade
Listed by Imedicom Co., Ltd., South Korea
FDA product code HWE
Device type Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
Device class Class 1
Regulation 21 CFR 878.4820
Establishment Manufacturer, Exporter
Premarket notification Exempt
Record published 2020-06-17
Record revised 2021-01-22 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Label carries lot or batch number, expiry date

Catalogue Numbers

Catalogue numbers for Brasseler EZX Blade
Catalogue number Size Status
BRXTB590 In distribution
BRXTB540 In distribution
BRXTB730 In distribution
BRXTB480 In distribution
BRXTB570 In distribution
BRXTB710 In distribution
BRXTB560 In distribution
BRXTB500 In distribution
BRXTB650 In distribution
BRXTB470 In distribution
BRXTB700 In distribution
BRXTB580 In distribution
BRXTB690 In distribution
BRXTB550 In distribution
BRXTB670 In distribution
BRXTB620 In distribution
BRXTB680 In distribution
BRXTB630 In distribution
BRXTB490 In distribution
BRXTB610 In distribution
BRXTB510 In distribution
BRXTB600 In distribution
BRXTB660 In distribution
BRXTB720 In distribution
BRXTB740 In distribution
BRXTB530 In distribution
BRXTB460 In distribution
BRXTB640 In distribution
BRXTB520 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
EZX Imedicom Co., Ltd. 441
Arthrex® Arthrex, Inc. 391
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment Stryker GmbH 284
Medicon Medicon eG. Chirurgiemechaniker-Genossenschaft 231
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment Synthes Gmbh 226
Brasseler EZX Imedicom Co., Ltd. 187
Conserve® Microport Orthopedics Inc. 158
R3 Smith & Nephew, Inc. 147
Trigen Smith & Nephew, Inc. 139
MicroPort Microport Orthopedics Inc. 134
Made-To-Order Tornier Inc. 131
Profemur® Microport Orthopedics Inc. 129

Showing 12 of 1,081. All products under Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

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