CorticaLINK MI

Extended Tab Cancellous Screw: 5.5mm X 60mm

Registry build 21.09.26
13manufacturers in China registered for this device type
32catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (7), Shanghai (2), Shandong (2). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code MNH
Manufacturer City Province Registered as Device types
Apex (Guangzhou) Tools & Orthopedics Company Guangzhou Guangdong Contract manufacturer 62
Changzhou Biomet Medical Devices Co., Ltd. Changzhou Jiangsu Contract manufacturer 54
APS Materials Suzhou Suzhou Jiangsu Contract manufacturer 18
Zibo Dante Co., Ltd. Zibo Shandong Contract manufacturer 17
Shanghai JPY ION-Tech Co., Ltd. Shanghai Shanghai Contract manufacturer 70
Medtronic (Changzhou) Medical Devices Technology Co., Ltd. Changzhou Jiangsu Manufacturer 53
Shandong Weigao Orthopaedic Device Co., Ltd. Weihai Shandong Contract manufacturer 42
Johnson & Johnson Medical (Depuy – Suzhou) Ltd. Suzhou Jiangsu Manufacturer 34
Double Medical Technology Inc. Xiamen Fujian Contract manufacturer 14
Suzhou Kangli Orthopaedics Instrument Co., Ltd. Zhangjiagang Jiangsu Contract manufacturer 11
Changzhou Yonghua Medical Instruments Co., Ltd. Changzhou Jiangsu Manufacturer 8
Jiangsu Ideal Medical Science & Technology Co., Ltd. Zhangjiagang Jiangsu Contract manufacturer 7

Showing 12 of 13. All 13 manufacturers in China registered for Orthosis, Spondylolisthesis Spinal Fixation

Record

Regulatory record for CorticaLINK MI
Listed by Linkspine, Inc., United States
FDA product code MNH
Device type Orthosis, Spondylolisthesis Spinal Fixation
Device class Class 2
Regulation 21 CFR 888.3070
Record published 2017-12-22
Record revised 2025-07-02 (version 4)

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
Sizes Length 25 to 200 mm; outer diameter 5 to 7.5 mm

Catalogue Numbers

Catalogue numbers for CorticaLINK MI
Catalogue number Size Status
80-4205/025 Length 25 mm In distribution
80-4200/025 Length 25 mm In distribution
80-4200/065 Length 65 mm In distribution
80-4200/055 Length 55 mm In distribution
80-4205/130 Length 130 mm In distribution
80-4205/200 Length 200 mm In distribution
80-4205/110 Length 110 mm In distribution
80-4205/070 Length 70 mm In distribution
80-4205/050 Length 50 mm In distribution
80-4210/5560 Outer Diameter 5.5 mm In distribution
80-4210/5540 Outer Diameter 5.5 mm In distribution
80-4200/035 Length 35 mm In distribution
80-4200/045 Length 45 mm In distribution
80-4200/140 Length 140 mm In distribution
80-4205/045 Length 45 mm In distribution
80-4205/090 Length 90 mm In distribution
80-4210/7550 Outer Diameter 7.5 mm In distribution
80-4210/6545 Outer Diameter 6.5 mm In distribution
80-4200/120 Length 120 mm In distribution
80-4210/7530 Outer Diameter 7.5 mm In distribution
80-4205/060 Length 60 mm In distribution
80-4205/150 Length 150 mm In distribution
80-4210/6555 Outer Diameter 6.5 mm In distribution
80-4200/080 Length 80 mm In distribution
80-4200/100 Length 100 mm In distribution
80-4210/7540 Outer Diameter 7.5 mm In distribution
80-4205/030 Length 30 mm In distribution
80-4210/6535 Outer Diameter 6.5 mm In distribution
80-4200/160 Length 160 mm In distribution
80-4210/5530 Outer Diameter 5.5 mm In distribution
80-4210/7560 Outer Diameter 7.5 mm In distribution
80-4210/5550 Outer Diameter 5.5 mm In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
CD Horizon® Spinal System Medtronic Sofamor Danek, Inc. 3,144
Anax™ 5.5 Spinal System CG MedTech Co., Ltd. 2,177
ReLine Nuvasive, Inc. 2,010
Creo Globus Medical, Inc. 1,619
Perfix™ Spinal System CG MedTech Co., Ltd. 1,476
Apex Spine System Spinecraft LLC 1,193
Olympic Astura Medical 1,173
Arsenal Alphatec Spine, Inc. 1,001
Revere Globus Medical, Inc. 997
Astra Spine System Spinecraft LLC 798
Apex-DL Spine System Spinecraft LLC 735
Zenius Spinal System Medyssey Co., Ltd. 712

Showing 12 of 811. All products under Orthosis, Spondylolisthesis Spinal Fixation

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