4CIS Sara/Vertu Spine System
The 4CIS Sara/Vertu rod is a longitudinal component of a posterior spinal fixation construct. It joins the system's pedicle screws and locking components to provide immobilization and…
The 4CIS Sara/Vertu rod is a longitudinal component of a posterior spinal fixation construct. It joins the system’s pedicle screws and locking components to provide immobilization and stabilization as an adjunct to fusion.
The top-loading system uses screws, rods, nuts and transverse links in configurations selected for mature patient anatomy. Implants are supplied nonsterile for single use and are made from titanium or cobalt-chromium alloys.
Listed Item
Rod: Ø 5.5 mm, Length 280 mm , Straight end, Make: Titanium alloy (Ti-6A1-4V ELI) conforms to ASTM F136
Fusion Conditions
Applications include thoracic, lumbar and sacral instability or deformity. For severe Grade III or IV L5-S1 spondylolisthesis, the system is used with autogenous graft and L3-to-sacrum fixation, with implant removal after solid fusion.
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 | 2021-03-30 |
| Record revised | 2025-07-02 (version 2) |
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-1507-5528 | In distribution | |
| AISP-1506-5509 | In distribution | |
| AISP-1506-5515 | In distribution | |
| AISP-1519-5506 | In distribution | |
| AISP-1507-5519 | In distribution | |
| AISP-1703-4053 | In distribution | |
| AISP-1506-5504 | In distribution | |
| AISP-1506-5523 | In distribution | |
| AISP-1517-5501 | In distribution | |
| AISP-1506-5525 | In distribution | |
| AISP-1507-5517 | In distribution | |
| AISP-1519-5513 | In distribution | |
| AISP-1519-5519 | In distribution | |
| AISP-1507-5514 | In distribution | |
| AISP-1506-5519 | In distribution | |
| AISP-1519-5516 | In distribution | |
| AISP-1507-5506 | In distribution | |
| AISP-1506-5518 | In distribution | |
| AISP-1519-5510 | In distribution | |
| AISP-1703-3846 | In distribution | |
| AISP-1506-5529 | In distribution | |
| AISP-1506-5514 | In distribution | |
| AISP-1506-5521 | In distribution | |
| AISP-1506-5517 | In distribution | |
| AISP-1519-5518 | In distribution | |
| AISP-1506-5505 | In distribution | |
| AISP-1507-5505 | In distribution | |
| AISP-1506-5508 | In distribution | |
| AISP-1519-5505 | In distribution | |
| AISP-1507-5550 | In distribution | |
| AISP-1506-5545 | In distribution | |
| AISP-1507-5516 | In distribution | |
| AISP-1507-5526 | In distribution | |
| AISP-1703-3034 | In distribution | |
| AISP-1507-5515 | In distribution | |
| AISP-1506-5530 | In distribution | |
| AISP-1506-5527 | In distribution | |
| AISP-1507-5535 | In distribution | |
| AISP-1517-5501 | In distribution | |
| AISP-1506-5510 | In distribution | |
| AISP-1506-5528 | In distribution | |
| AISP-1507-5545 | In distribution | |
| AISP-1507-5511 | In distribution | |
| AISP-1507-5520 | In distribution | |
| AISP-1519-5507 | In distribution | |
| AISP-1519-5512 | In distribution | |
| AISP-1506-5526 | In distribution | |
| AISP-1507-5507 | In distribution | |
| AISP-1506-5512 | In distribution | |
| AISP-1507-5508 | In distribution | |
| AISP-1507-5527 | In distribution | |
| AISP-1507-5522 | In distribution | |
| AISP-1506-5513 | In distribution | |
| AISP-1507-5530 | In distribution | |
| AISP-1519-5514 | In distribution | |
| AISP-1519-5504 | In distribution | |
| AISP-1519-5520 | In distribution | |
| AISP-1507-5504 | In distribution | |
| AISP-1506-5524 | In distribution | |
| AISP-1703-5070 | In distribution | |
| AISP-1519-5508 | In distribution | |
| AISP-1506-5550 | In distribution | |
| AISP-1506-5507 | In distribution | |
| AISP-1507-5529 | In distribution | |
| AISP-1507-5540 | In distribution | |
| AISP-1507-5521 | In distribution | |
| AISP-1506-5522 | In distribution | |
| AISP-1703-3442 | In distribution | |
| AISP-1507-5518 | In distribution | |
| AISP-1519-5509 | In distribution | |
| AISP-1519-5515 | In distribution | |
| AISP-1506-5540 | In distribution | |
| AISP-1506-5511 | In distribution | |
| AISP-1506-5506 | In distribution | |
| AISP-1507-5509 | In distribution | |
| AISP-1507-5510 | In distribution | |
| AISP-1506-5535 | In distribution | |
| AISP-1507-5512 | In distribution | |
| AISP-1506-5516 | In distribution | |
| AISP-1507-5523 | In distribution | |
| AISP-1507-5525 | In distribution | |
| AISP-1507-5524 | In distribution | |
| AISP-1506-5520 | In distribution | |
| AISP-1519-5511 | In distribution | |
| AISP-1519-5517 | In distribution | |
| AISP-1507-5513 | In distribution |
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.