CD Horizon Spinal System

Screw 25740011111 BS Cnmas 11.5X110 TC S

Registry build 21.09.26
23manufacturers in China registered for this device type
38catalogue 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 CD Horizon Spinal System
Listed by Medtronic Sofamor Danek, 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
510(k) K153463
Record published 2016-04-16
Record revised 2024-09-19 (version 6)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Latex Labelled latex-free
Label carries lot or batch number
Sizes Outer diameter 5 to 5.5 mm
Distribution end date 2023-11-01

Catalogue Numbers

Catalogue numbers for CD Horizon Spinal System
Catalogue number Size Status
6641100 4.5-5.5 mm In distribution
25840011270 In distribution
25740011111 In distribution
25840019560 In distribution
25100095 In distribution
25530017590 In distribution
X1013208 6.35mm In distribution
25630011090 In distribution
25630011270 In distribution
6641150 Outer Diameter 5.0 mm In distribution
6641055 Outer Diameter 5.5 mm In distribution
6641105 5.5-6.5 mm In distribution
NAV0075 In distribution
NAV1105 In distribution
25530018580 In distribution
X1013206 6.35mm In distribution
25100075 In distribution
25630017590 In distribution
25530018570 In distribution
25530011290 In distribution
25630011290 In distribution
25740018513 In distribution
25530011150 In distribution
25630011080 In distribution
25840017510 In distribution
NAV6640007 In distribution
X1013202 In distribution
25740018550 In distribution
25630017580 In distribution
25740011190 In distribution
X1013188 10.5mm Withdrawn
25840018513 Withdrawn
25740011213 Withdrawn
X1013185 9.0mm Withdrawn
25630011013 Withdrawn
25530011212 Withdrawn
25840019513 Withdrawn
25630011212 Withdrawn

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