4CIS Vertu Spine System
4CIS Vertu is a posterior spinal fixation family for stabilization as an adjunct to fusion. Pedicle screws, rods, nuts and transverse crosslinks lock together into a construct suited to the…
4CIS Vertu is a posterior spinal fixation family for stabilization as an adjunct to fusion. Pedicle screws, rods, nuts and transverse crosslinks lock together into a construct suited to the patient’s anatomy.
The top-loading system anchors through the vertebral pedicles and uses an open posterior approach. A listed mono-axial cannulated reduction screw is one implant component in the broader screw-and-rod family.
Listed Item
Mono-axial Reduction Cannulated Pedicle Screw, Ø 7.5 mm, 100 mm Length The Spinal Fixation System is a top-loading posterior spinal fixation system which consists of pedicle screws, rods, nuts, transverse (cross) link and associated instruments. Rigid fixation is provided by pedicle screws inserted into the vertebral body through pedicle of the lumbar spine via posterior approach. This system will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion through open surgery. Implant components can be rigidly locked into a variety of different configurations to suit the individual pathology and anatomical conditions of the mature patient. The implant components are supplied non-sterile single use and are fabricated from titanium alloy (Ti-6A1-4V ELI) conforms to ASTM F136. Also, Specialized instruments are available for the application and removal of the Spinal Fixation System
Materials and Instruments
The implant range uses titanium alloy and cobalt-chromium alloy across its components. Implants are supplied nonsterile for single use. Specialized instruments support application and removal of the construct, while the selected implant configuration provides immobilization of the treated spinal segments.
15manufacturers in China registered for this device type
295catalogue 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 | Solco Biomedical Company India Private Limited, India |
|---|---|
| FDA product code | NKB |
| Device type | Thoracolumbosacral Pedicle Screw System |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Establishment | Contract manufacturer, Contract steriliser, Manufacturer |
| 510(k) | K202498 |
| Record published | 2021-03-27 |
| Record revised | 2026-05-14 (version 3) |
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 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AISP-2806-6540 | In distribution | |
| AISP-2808-7550 | In distribution | |
| AISP-2805-7590 | In distribution | |
| AISP-2805-6560 | In distribution | |
| AISP-2806-7080 | In distribution | |
| AISP-2807-6595 | In distribution | |
| AISP-2807-7535 | In distribution | |
| AISP-1035-7555 | In distribution | |
| AISP-2805-7095 | In distribution | |
| AISP-1037-7545 | In distribution | |
| AISP-1036-7580 | In distribution | |
| AISP-2808-6545 | In distribution | |
| AISP-2806-6555 | In distribution | |
| AISP-2807-7060 | In distribution | |
| AISP-1036-7085 | In distribution | |
| AISP-1036-6580 | In distribution | |
| AISP-2808-7050 | In distribution | |
| AISP-1035-6590 | In distribution | |
| AISP-2808-7540 | In distribution | |
| AISP-2808-6555 | In distribution | |
| AISP-2806-6575 | In distribution | |
| AISP-1035-7090 | In distribution | |
| AISP-2805-6535 | In distribution | |
| AISP-2807-7545 | In distribution | |
| AISP-1036-7050 | In distribution | |
| AISP-2808-6550 | In distribution | |
| AISP-1036-6560 | In distribution | |
| AISP-1036-7095 | In distribution | |
| AISP-2806-6535 | In distribution | |
| AISP-2808-7040 | In distribution | |
| AISP-2805-6565 | In distribution | |
| AISP-2806-7555 | In distribution | |
| AISP-2806-6570 | In distribution | |
| AISP-1037-7040 | In distribution | |
| AISP-1037-7060 | In distribution | |
| AISP-1036-7545 | In distribution | |
| AISP-2808-7045 | In distribution | |
| AISP-1035-7085 | In distribution | |
| AISP-1035-7595 | In distribution | |
| AISP-1037-6535 | In distribution | |
| AISP-2806-7595 | In distribution | |
| AISP-1035-6540 | In distribution | |
| AISP-2807-6570 | In distribution | |
| AISP-2808-7075 | In distribution | |
| AISP-1037-7050 | In distribution | |
| AISP-1035-7065 | In distribution | |
| AISP-2805-7575 | In distribution | |
| AISP-1037-7565 | In distribution | |
| AISP-2807-6550 | In distribution | |
| AISP-1036-7560 | In distribution | |
| AISP-2807-6535 | In distribution | |
| AISP-2807-7050 | In distribution | |
| AISP-2806-7580 | In distribution | |
| AISP-1035-7040 | In distribution | |
| AISP-2807-6555 | In distribution | |
| AISP-1035-6550 | In distribution | |
| AISP-1036-7060 | In distribution | |
| AISP-2805-7540 | In distribution | |
| AISP-1038-7050 | In distribution | |
| AISP-1035-7080 | In distribution | |
| AISP-2806-6550 | In distribution | |
| AISP-1037-7555 | In distribution | |
| AISP-1035-7580 | In distribution | |
| AISP-1036-6535 | In distribution | |
| AISP-2805-7570 | In distribution | |
| AISP-1035-7565 | In distribution | |
| AISP-2808-6580 | In distribution | |
| AISP-1035-6555 | In distribution | |
| AISP-1036-7035 | In distribution | |
| AISP-2807-7570 | In distribution | |
| AISP-2805-7050 | In distribution | |
| AISP-2805-7585 | In distribution | |
| AISP-2807-7010 | In distribution | |
| AISP-2806-7545 | In distribution | |
| AISP-2808-6585 | In distribution | |
| AISP-2806-6590 | In distribution | |
| AISP-2808-7510 | In distribution | |
| AISP-1035-7055 | In distribution | |
| AISP-1037-7055 | In distribution | |
| AISP-2808-7070 | In distribution | |
| AISP-1038-7040 | In distribution | |
| AISP-1038-7535 | In distribution | |
| AISP-2807-7580 | In distribution | |
| AISP-1038-7540 | In distribution | |
| AISP-2806-7070 | In distribution | |
| AISP-2805-6510 | In distribution | |
| AISP-1036-7090 | In distribution | |
| AISP-2805-7075 | In distribution | |
| AISP-1038-6550 | In distribution | |
| AISP-1035-6510 | In distribution | |
| AISP-1038-7055 | In distribution | |
| AISP-2807-6560 | In distribution | |
| AISP-1036-6510 | In distribution | |
| AISP-2805-7510 | In distribution | |
| AISP-2805-7550 | In distribution | |
| AISP-1036-7550 | In distribution | |
| AISP-2806-7010 | In distribution | |
| AISP-2805-6555 | In distribution | |
| AISP-1035-6595 | In distribution | |
| AISP-2807-7045 | In distribution | |
| AISP-2808-7560 | In distribution | |
| AISP-2805-6595 | In distribution | |
| AISP-1035-7575 | In distribution | |
| AISP-2805-7560 | In distribution | |
| AISP-2806-7510 | In distribution | |
| AISP-2805-6580 | In distribution | |
| AISP-2807-7590 | In distribution | |
| AISP-2805-6590 | In distribution | |
| AISP-2807-7595 | In distribution | |
| AISP-2808-7570 | In distribution | |
| AISP-1037-7560 | In distribution | |
| AISP-2806-6510 | In distribution | |
| AISP-2808-6590 | In distribution | |
| AISP-2808-7080 | In distribution | |
| AISP-2805-7555 | In distribution | |
| AISP-2808-6540 | In distribution | |
| AISP-2808-6560 | In distribution | |
| AISP-1035-7035 | In distribution | |
| AISP-1035-7560 | In distribution | |
| AISP-2808-6575 | In distribution | |
| AISP-2805-7090 | In distribution | |
| AISP-1035-7050 | In distribution | |
| AISP-2806-7075 | In distribution | |
| AISP-2807-6580 | In distribution | |
| AISP-1036-7585 | In distribution | |
| AISP-2806-7560 | In distribution | |
| AISP-1036-7575 | In distribution | |
| AISP-2808-7095 | In distribution | |
| AISP-2805-7565 | In distribution | |
| AISP-1036-6570 | In distribution | |
| AISP-1037-6550 | In distribution | |
| AISP-1036-7590 | In distribution | |
| AISP-1038-7060 | In distribution | |
| AISP-2806-7590 | In distribution | |
| AISP-2807-6540 | In distribution | |
| AISP-2805-7580 | In distribution | |
| AISP-2807-7555 | In distribution | |
| AISP-1038-6535 | In distribution | |
| AISP-1036-7070 | In distribution | |
| AISP-2807-7055 | In distribution | |
| AISP-2805-7010 | In distribution | |
| AISP-2805-6585 | In distribution | |
| AISP-1037-7035 | In distribution | |
| AISP-2805-7055 | In distribution | |
| AISP-1038-7045 | In distribution | |
| AISP-2808-6510 | In distribution | |
| AISP-2808-6535 | In distribution | |
| AISP-1035-6535 | In distribution | |
| AISP-1038-6565 | In distribution | |
| AISP-1037-6545 | In distribution | |
| AISP-2806-6580 | In distribution | |
| AISP-2808-7590 | In distribution | |
| AISP-1036-7535 | In distribution | |
| AISP-2805-6540 | In distribution | |
| AISP-2808-7565 | In distribution | |
| AISP-1036-7555 | In distribution | |
| AISP-1035-7045 | In distribution | |
| AISP-2805-6570 | In distribution | |
| AISP-1037-7535 | In distribution | |
| AISP-1035-7075 | In distribution | |
| AISP-2805-7045 | In distribution | |
| AISP-1035-7590 | In distribution | |
| AISP-1035-7545 | In distribution | |
| AISP-1035-6570 | In distribution | |
| AISP-1038-6545 | In distribution | |
| AISP-2808-7055 | In distribution | |
| AISP-1036-6595 | In distribution | |
| AISP-2808-7085 | In distribution | |
| AISP-1037-6565 | In distribution | |
| AISP-2808-7035 | In distribution | |
| AISP-2805-7085 | In distribution | |
| AISP-2807-7565 | In distribution | |
| AISP-1036-6565 | In distribution | |
| AISP-2808-6565 | In distribution | |
| AISP-2807-7040 | In distribution | |
| AISP-1035-6585 | In distribution | |
| AISP-2807-7560 | In distribution | |
| AISP-2806-7550 | In distribution | |
| AISP-2805-7545 | In distribution | |
| AISP-2806-7050 | In distribution | |
| AISP-1036-7045 | In distribution | |
| AISP-2807-7540 | In distribution | |
| AISP-2807-7085 | In distribution | |
| AISP-1035-7570 | In distribution | |
| AISP-2808-7060 | In distribution | |
| AISP-1036-7540 | In distribution | |
| AISP-1037-6540 | In distribution | |
| AISP-2807-7075 | In distribution | |
| AISP-2808-7580 | In distribution | |
| AISP-1036-7065 | In distribution | |
| AISP-2807-7510 | In distribution | |
| AISP-1035-6560 | In distribution | |
| AISP-2807-6590 | In distribution | |
| AISP-2806-7565 | In distribution | |
| AISP-1036-6540 | In distribution | |
| AISP-1038-7560 | In distribution | |
| AISP-2806-7585 | In distribution | |
| AISP-2808-7555 | In distribution | |
| AISP-1036-6590 | In distribution | |
| AISP-2805-7595 | In distribution | |
| AISP-1035-7510 | In distribution | |
| AISP-1035-7060 | In distribution | |
| AISP-1038-7550 | In distribution | |
| AISP-2807-7090 | In distribution | |
| AISP-1037-6560 | In distribution | |
| AISP-1038-7555 | In distribution | |
| AISP-2807-6565 | In distribution | |
| AISP-2806-7540 | In distribution | |
| AISP-2807-6575 | In distribution | |
| AISP-2806-7090 | In distribution | |
| AISP-1038-6560 | In distribution | |
| AISP-2808-6570 | In distribution | |
| AISP-1039-0001 | Dia. 10.0 x 4.8 mm | In distribution |
| AISP-2806-7060 | In distribution | |
| AISP-1038-7035 | In distribution | |
| AISP-2805-7535 | In distribution | |
| AISP-2805-7080 | In distribution | |
| AISP-2808-7010 | In distribution | |
| AISP-1035-7070 | In distribution | |
| AISP-1036-6575 | In distribution | |
| AISP-2808-7065 | In distribution | |
| AISP-1035-7095 | In distribution | |
| AISP-2806-7035 | In distribution | |
| AISP-1035-7535 | In distribution | |
| AISP-2806-7535 | In distribution | |
| AISP-1038-7065 | In distribution | |
| AISP-1036-7570 | In distribution | |
| AISP-2807-6585 | In distribution | |
| AISP-2805-7060 | In distribution | |
| AISP-2806-6565 | In distribution | |
| AISP-2807-7070 | In distribution | |
| AISP-2808-7575 | In distribution | |
| AISP-2806-7095 | In distribution | |
| AISP-2806-6560 | In distribution | |
| AISP-2807-7065 | In distribution | |
| AISP-2806-7085 | In distribution | |
| AISP-2808-7090 | In distribution | |
| AISP-1035-6545 | In distribution | |
| AISP-2805-7065 | In distribution | |
| AISP-2805-7040 | In distribution | |
| AISP-1036-7565 | In distribution | |
| AISP-1036-7055 | In distribution | |
| AISP-1037-7045 | In distribution | |
| AISP-2806-6585 | In distribution | |
| AISP-2807-7095 | In distribution | |
| AISP-1038-6555 | In distribution | |
| AISP-1035-6580 | In distribution | |
| AISP-2808-7535 | In distribution | |
| AISP-2807-7080 | In distribution | |
| AISP-2806-7575 | In distribution |
Showing 250 of 295 catalogue numbers.
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 |
|---|---|
| K202498 | 2021-02-18 |
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.