4CIS® Chiron Spinal Fixation System
4CIS® Chiron-XT Poly Cannulated Screw (Half Closed Type) Ø8.0 X 70mm (Rod Ø5.5)
15manufacturers in China registered for this device type
3,787catalogue numbers in this listing
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 | Alpha AI Co., Ltd., South Korea |
|---|---|
| FDA product code | NKB |
| Device type | Thoracolumbosacral Pedicle Screw System |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Establishment | Manufacturer |
| 510(k) | K190471 |
| Record published | 2019-08-13 |
| Record revised | 2026-01-19 (version 5) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 4124-70B5 | In distribution | |
| 4128-8080 | In distribution | |
| 4148-8065 | In distribution | |
| 4146-90C0 | In distribution | |
| 4136-7025 | In distribution | |
| 4150-7040 | In distribution | |
| 4149-80D0 | In distribution | |
| 4339-6040 | In distribution | |
| 4135-85E5 | In distribution | |
| 4125-75A5 | In distribution | |
| 4129-4025 | In distribution | |
| 4136-4535 | In distribution | |
| 4128-7580 | In distribution | |
| 4135-7085 | In distribution | |
| 4138-4545 | In distribution | |
| 4147-5530 | In distribution | |
| 4151-8070 | In distribution | |
| 4127-7075 | In distribution | |
| 4145-70A0 | In distribution | |
| 4138-90F0 | In distribution | |
| 4146-9565 | In distribution | |
| 4150-5045 | In distribution | |
| 4147-9080 | In distribution | |
| 4149-8060 | In distribution | |
| 4138-8040 | In distribution | |
| 4146-7555 | In distribution | |
| 4129-65E0 | In distribution | |
| 4145-9065 | In distribution | |
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| 4144-8595 | In distribution | |
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| 4129-4560 | In distribution | |
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| 4129-8070 | In distribution | |
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| 4125-8590 | In distribution | |
| 4145-6040 | In distribution | |
| 4150-4545 | In distribution | |
| 4149-9520 | In distribution | |
| 4145-6595 | In distribution | |
| 4138-85E5 | In distribution | |
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| 4124-75B0 | In distribution | |
| 4126-85A5 | In distribution | |
| 4125-6580 | In distribution | |
| 4125-80C0 | In distribution | |
| 4150-6030 | In distribution | |
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| 4126-7075 | In distribution | |
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| 4145-7020 | In distribution | |
| 4147-9060 | In distribution | |
| 4148-5560 | In distribution | |
| 4125-5540 | In distribution | |
| 4145-9585 | In distribution | |
| 4338-5140 | In distribution | |
| 4144-65C0 | In distribution | |
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| 4338-5555 | In distribution | |
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| 4144-7525 | In distribution | |
| 4137-9070 | In distribution | |
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| 4124-7075 | In distribution | |
| 4128-7065 | In distribution | |
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Showing 250 of 300 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 |
| 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 |
| Vital™ | Biomet Spine | 2,355 |
Showing 12 of 1,490. All products under Thoracolumbosacral Pedicle Screw System
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.