CorticaLINK
Cortical Screw, Non-Cannulated: 5.0mm X 35mm
15manufacturers in China registered for this device type
53catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Jiangsu (6), Shanghai (3), Shandong (3). 6 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| 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 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| 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 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
| Shanghai Reach Medical Instrument Co., Ltd. | Shanghai | Shanghai | Manufacturer | 30 |
| Changzhou Geasure Medical Apparatus AND Instruments Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 25 |
| Double Medical Technology Inc. | Xiamen | Fujian | Contract manufacturer | 14 |
Showing 12 of 15. All 15 manufacturers in China registered for Thoracolumbosacral Pedicle Screw System
Record
| Listed by | Linkspine, Inc., United States |
|---|---|
| FDA product code | NKB |
| Device type | Thoracolumbosacral Pedicle Screw System |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| 510(k) | K160722 |
| Record published | 2018-07-06 |
| Record revised | 2025-07-02 (version 6) |
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 100 mm; outer diameter 4.5 to 7.5 mm |
| Distribution end date | 2017-03-09 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 80-4000F | In distribution | |
| 80-4015/6540 | Length 40 mm | In distribution |
| 80-4014/7540 | Length 40 mm | In distribution |
| 80-4012/070 | Length 70 mm | In distribution |
| 80-4013/025 | Length 25 mm | In distribution |
| 80-4014/5530 | Length 30 mm | In distribution |
| 80-4017/5035 | Length 35 mm | In distribution |
| 80-4004/5040 | Length 40 mm | In distribution |
| 80-4003/060 | Length 60 mm | In distribution |
| 80-4015/5555 | Length 55 mm | In distribution |
| 80-4004/5030 | Length 30 mm | In distribution |
| 80-4013/065 | Outer Diameter 5.0 mm | In distribution |
| 80-4015/5535 | Length 35 mm | In distribution |
| 80-4013/045 | Length 45 mm | In distribution |
| 80-4015/6550 | Length 50 mm | In distribution |
| 80-4003/100 | Length 100 mm | In distribution |
| 80-4017/5025 | Length 25 mm | In distribution |
| 80-4014/7550 | Length 50 mm | In distribution |
| 80-4012/050 | Length 50 mm | In distribution |
| 80-4015/5545 | Length 45 mm | In distribution |
| 80-4012/030 | Length 30 mm | In distribution |
| 80-4002/060 | Length 60 mm | In distribution |
| 80-4014/7560 | Length 60 mm | In distribution |
| 80-4014/5550 | Length 50 mm | In distribution |
| 80-4014/6555 | Length 55 mm | In distribution |
| 80-4004/4545 | Length 45 mm | In distribution |
| 80-4003/040 | Length 40 mm | In distribution |
| 80-4004/4535 | Length 35 mm | In distribution |
| 80-4013/035 | Length 35 mm | In distribution |
| 80-4014/5540 | Length 40 mm | In distribution |
| 80-4013/100 | Outer Diameter 5.0 mm | In distribution |
| 80-4003/030 | Length 30 mm | In distribution |
| 80-4014/6535 | Length 35 mm | In distribution |
| 80-4014/6545 | Length 45 mm | In distribution |
| 80-4006/5040 | Length 40 mm | In distribution |
| 80-4017/5045 | Length 45 mm | In distribution |
| 80-4002/100 | Length 100 mm | In distribution |
| 80-4012/040 | Length 40 mm | In distribution |
| 80-4004/5050 | Length 50 mm | In distribution |
| 80-4002/030 | Length 30 mm | In distribution |
| 80-4000M | In distribution | |
| 80-4006/5030 | Length 30 mm | In distribution |
| 80-4015/6530 | Length 30 mm | In distribution |
| 80-4013/055 | Outer Diameter 5.0 mm | In distribution |
| 80-4014/5560 | Length 60 mm | In distribution |
| 80-4004/4525 | Length 25 mm | In distribution |
| 80-4012/060 | Length 60 mm | In distribution |
| 80-4014/7530 | Length 30 mm | In distribution |
| 80-4002/040 | Length 40 mm | In distribution |
| 80-4015/6560 | Length 60 mm | In distribution |
| 80-4006/4535 | Length 35 mm | Withdrawn |
| 80-4006/4545 | Length 45 mm | Withdrawn |
| 80-4006/4525 | Length 25 mm | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| The Jasper Spinal Fixation System | Gbs Commonwealth Co., Ltd. | 32,491 |
| Invictus | Alphatec Spine, Inc. | 4,722 |
| Vital Spinal Fixation System | Highridge Medical, LLC | 4,422 |
| Innoverse Spinal System | CG MedTech Co., Ltd. | 4,240 |
| 4CIS® Chiron Spinal Fixation System | Alpha AI Co., Ltd. | 3,787 |
| LnK Spinal Fixation System | L&K Biomed Co., Ltd. | 3,522 |
| Hedjet System | Medyssey Co., Ltd. | 3,438 |
| Anax™ 5.5 Spinal System | CG MedTech Co., Ltd. | 3,424 |
| Mega Plus MIS Spine System | BK Meditech Co., Ltd. | 3,396 |
| ReLine | Nuvasive, Inc. | 2,882 |
| Nex-D2 | Next Orthosurgical | 2,765 |
| AnyPlus Spinal Fixation System | GS Medical Co., Ltd. | 2,386 |
Showing 12 of 1,490. All products under Thoracolumbosacral Pedicle Screw System
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K173484 | 2017-12-11 |
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.