Fuse Ultra Foot Plating System

Torx Driver, Non-Cannulated,Long, AO QC, T10

Registry build 21.09.26
23manufacturers in China registered for this device type
49catalogue 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 Fuse Ultra Foot Plating System
Listed by CPM Medical Consultants, LLC., 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 Specification developer, Complaint-file establishment, Manufacturer
510(k) K141784
Record published 2025-07-16
Record revised 2025-03-19 (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
Over the counter Yes
Label carries lot or batch number

Catalogue Numbers

Catalogue numbers for Fuse Ultra Foot Plating System
Catalogue number Size Status
OS216093 In distribution
OS200125ST In distribution
OS200125 In distribution
R200516 In distribution
OS023020 In distribution
OS2013209 In distribution
OS200115L In distribution
OS328028L In distribution
OS200132S In distribution
OS2013166 In distribution
OS200127 In distribution
OS2016166 In distribution
OS200618 In distribution
OS200520 In distribution
OS000001 In distribution
OS200120L In distribution
OS2013116 In distribution
OS200145 In distribution
OS2013096 In distribution
R200622 In distribution
OS2013206 In distribution
OS200518 In distribution
OS200622 In distribution
OS200132 In distribution
OS200127L In distribution
OS200620 In distribution
OS200125L In distribution
R200522 In distribution
OS200128 In distribution
OS200115 In distribution
R200518 In distribution
OS200128S In distribution
OS200135 In distribution
OS200132L In distribution
OS200145L In distribution
OS200522 In distribution
OS200120 In distribution
OS200118 In distribution
OS200516 In distribution
OS328021 In distribution
R200618 In distribution
OS200135L In distribution
R200620 In distribution
OS200616 In distribution
R200616 In distribution
OS2016116 In distribution
OS2016206 In distribution
R200520 In distribution
OS200160L 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