Evolution®

Evolution® HEX / PIN Driver

Registry build 21.09.26
23manufacturers in China registered for this device type
58catalogue 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 Evolution®
Listed by Microport Orthopedics Inc., United States
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 Contract manufacturer, Reprocessor, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter
Premarket notification Exempt
Record published 2020-05-28
Record revised 2018-03-29 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Single use Yes
Prescription Prescription only
Label carries lot or batch number, manufacturing date

Catalogue Numbers

Catalogue numbers for Evolution®
Catalogue number Size Status
E5001004CN In distribution
E2431235 In distribution
E2431175 In distribution
E2431135 In distribution
E6001007 In distribution
E2431145 In distribution
E2431200 In distribution
E2001212 In distribution
E2431115 In distribution
E2431215 In distribution
E2431110 In distribution
E2431001 In distribution
E2431160 In distribution
E4200141 In distribution
E2001012 In distribution
E243118S In distribution
E4200132 In distribution
E2431150 In distribution
E2001238 In distribution
E4200025 In distribution
E4202028 In distribution
E4202025 In distribution
E2431205 In distribution
E2431100 In distribution
E2431180 In distribution
E4200135 In distribution
E2431210 In distribution
E5001004 In distribution
E2001138 In distribution
E2431195 In distribution
E2431230 In distribution
E4200028 In distribution
E2431003 In distribution
E2001038 In distribution
E2431140 In distribution
E2431240 In distribution
E2431190 In distribution
E5001005 In distribution
E2431185 In distribution
E2001112 In distribution
E2431120 In distribution
E2431225 In distribution
E4200232 In distribution
E4200138 In distribution
E4200235 In distribution
E4202047 In distribution
E2431125 In distribution
E2431220 In distribution
E0010000 In distribution
E2431170 In distribution
E4200241 In distribution
E2431002 In distribution
E2431105 In distribution
E2431155 In distribution
E5001005CN In distribution
E4200238 In distribution
E2431130 In distribution
E2431165 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