CorticaLINK
Cortical Screw, Non-Cannulated: 5.0mm X 30mm
13manufacturers in China registered for this device type
69catalogue 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.
| 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
| 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 |
| 510(k) | K160722 |
| Record published | 2017-02-05 |
| Record revised | 2025-07-02 (version 7) |
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 | Outer diameter 4.5 to 7.5 mm; length 25 to 200 mm |
| Distribution end date | 2017-03-09 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 80-4003/120 | Outer Diameter 5.0 mm | In distribution |
| 80-4012/090 | Outer Diameter 5.0 mm | In distribution |
| 80-4004/5035 | Outer Diameter 5.0 mm | In distribution |
| 80-4015/5530 | Outer Diameter 5.5 mm | In distribution |
| 80-4004/4540 | Outer Diameter 4.5 mm | In distribution |
| 80-4012/035 | Outer Diameter 5.0 mm | In distribution |
| 80-4014/5555 | Outer Diameter 5.5 mm | In distribution |
| 80-4015/6545 | Outer Diameter 6.5 mm | In distribution |
| 80-4013/120 | Outer Diameter 5.0 mm | In distribution |
| 80-4013/050 | Length 50 mm | In distribution |
| 80-4003/080 | Outer Diameter 5.0 mm | In distribution |
| 80-4014/6530 | Outer Diameter 6.5 mm | In distribution |
| 80-4015/5550 | Outer Diameter 5.5 mm | In distribution |
| 80-4004/4530 | Outer Diameter 4.5 mm | In distribution |
| 80-4003/035 | Outer Diameter 5.0 mm | In distribution |
| 80-4006/5045 | Outer Diameter 5.0 mm | In distribution |
| 80-4012/200 | Outer Diameter 5.0 mm | In distribution |
| 80-4014/7555 | Outer Diameter 7.5 mm | In distribution |
| 80-4012/120 | Outer Diameter 5.0 mm | In distribution |
| 80-4003/025 | Outer Diameter 5.0 mm | In distribution |
| 80-4002/110 | Outer Diameter 5.0 mm | In distribution |
| 80-4017/5030 | Outer Diameter 5.0 mm | In distribution |
| 80-4003/110 | Outer Diameter 5.0 mm | In distribution |
| 80-4012/110 | Outer Diameter 5.0 mm | In distribution |
| 80-4003/050 | Outer Diameter 5.0 mm | In distribution |
| 80-4015/5540 | Outer Diameter 5.5 mm | In distribution |
| 80-4003/200 | Outer Diameter 5.0 mm | In distribution |
| 80-4002/200 | Outer Diameter 5.0 mm | In distribution |
| 80-4014/6540 | Outer Diameter 6.5 mm | In distribution |
| 80-4001 | In distribution | |
| 80-4013/060 | Length 60 mm | In distribution |
| 80-4017/5040 | Outer Diameter 5.0 mm | In distribution |
| 80-4013/070 | Length 70 mm | In distribution |
| 80-4013/200 | Outer Diameter 5.0 mm | In distribution |
| 80-4012/055 | Outer Diameter 5.0 mm | In distribution |
| 80-4014/6560 | Outer Diameter 6.5 mm | In distribution |
| 80-4013/110 | Outer Diameter 5.0 mm | In distribution |
| 80-4013/090 | Outer Diameter 5.0 mm | In distribution |
| 80-4012/100 | Outer Diameter 5.0 mm | In distribution |
| 80-4002/120 | Outer Diameter 5.0 mm | In distribution |
| 80-4012/065 | Outer Diameter 5.0 mm | In distribution |
| 80-4014/7535 | Outer Diameter 7.5 mm | In distribution |
| 80-4012/025 | Outer Diameter 5.0 mm | In distribution |
| 80-4013/040 | Outer Diameter 5.0 mm | In distribution |
| 80-4002/070 | Outer Diameter 5.0 mm | In distribution |
| 80-4004/5045 | Outer Diameter 5.0 mm | In distribution |
| 80-4013/030 | Outer Diameter 5.0 mm | In distribution |
| 80-4015/6555 | Outer Diameter 6.5 mm | In distribution |
| 80-4002/050 | Outer Diameter 5.0 mm | In distribution |
| 80-4002/035 | Outer Diameter 5.0 mm | In distribution |
| 80-4003/070 | Outer Diameter 5.0 mm | In distribution |
| 80-4004/4550 | Outer Diameter 4.5 mm | In distribution |
| 80-4003/090 | Outer Diameter 5.0 mm | In distribution |
| 80-4012/080 | Outer Diameter 5.0 mm | In distribution |
| 80-4014/5535 | Outer Diameter 5.5 mm | In distribution |
| 80-4012/045 | Outer Diameter 5.0 mm | In distribution |
| 80-4004/5025 | Outer Diameter 5.0 mm | In distribution |
| 80-4002/025 | Outer Diameter 5.0 mm | In distribution |
| 80-4014/6550 | Outer Diameter 6.5 mm | In distribution |
| 80-4015/6535 | Outer Diameter 6.5 mm | In distribution |
| 80-4013/080 | Outer Diameter 5.0 mm | In distribution |
| 80-4014/7545 | Outer Diameter 7.5 mm | In distribution |
| 80-4015/5560 | Outer Diameter 5.5 mm | In distribution |
| 80-4006/5025 | Outer Diameter 5.0 mm | In distribution |
| 80-4006/5035 | Outer Diameter 5.0 mm | In distribution |
| 80-4002/090 | Outer Diameter 5.0 mm | In distribution |
| 80-4014/5545 | Outer Diameter 5.5 mm | In distribution |
| 80-4006/4530 | Outer Diameter 4.5 mm | Withdrawn |
| 80-4006/4540 | Outer Diameter 4.5 mm | Withdrawn |
Same 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.