Axis
Axis is the listed name for Southern Medical’s Axis Anterior Cervical Plate System. The FDA filing describes a system of bone plates and screws for anterior screw fixation to the cervical…
Axis is the listed name for Southern Medical’s Axis Anterior Cervical Plate System. The FDA filing describes a system of bone plates and screws for anterior screw fixation to the cervical spine.
The filing states that the system is intended as an adjunct to fusion from C2 to T1. Its listed indications include degenerative disc disease, trauma, deformity, spinal stenosis, pseudarthrosis and revision of previous surgery.
Listed Item
Axis Anterior Cervical Plate Screw, Variable, 45 x 16
Device Function and Details
The components are made from titanium alloy. The filing says the implants are supplied in sterile and non-sterile packaging.
Who Else Makes It
Concentrated in Jiangsu (5), Shanghai (3), Zhejiang (2). 8 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| 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 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| 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 |
| Double Medical Technology Inc. | Xiamen | Fujian | Contract manufacturer | 14 |
Showing 12 of 14. All 14 manufacturers in China registered for Appliance, Fixation, Spinal Intervertebral Body
Record
| Listed by | Southern Medical (PTY) Ltd, South Africa |
|---|---|
| FDA product code | KWQ |
| Device type | Appliance, Fixation, Spinal Intervertebral Body |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3060 |
| Establishment | Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K231145 |
| Record published | 2025-10-07 |
| Record revised | 2025-11-20 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CS45-16-T | In distribution | |
| CP3-3L-53 | In distribution | |
| CS45-12-T | In distribution | |
| CP3S-V45-16 | In distribution | |
| CS40-12-SD | In distribution | |
| CP3-3L-45 | In distribution | |
| CP3-2L-42.5 | In distribution | |
| CP3-2L-30 | In distribution | |
| CP3-2L-47.5 | In distribution | |
| CP3S-V40-20 | In distribution | |
| CP3S-V45-22 | In distribution | |
| CP3S-V40-14 | In distribution | |
| CP3-2L-32.5 | In distribution | |
| CP3-3L-61 | In distribution | |
| CP3S-V40-12 | In distribution | |
| CP3-2L-37.5 | In distribution | |
| CP3S-V45-18 | In distribution | |
| CP3-4L-83 | In distribution | |
| CP3S-V45-20 | In distribution | |
| CS40-16-SD | In distribution | |
| CP3S-V40-16 | In distribution | |
| CP3-4L-68 | In distribution | |
| CS45-22-T | In distribution | |
| CP3-3L-69 | In distribution | |
| CS40-18-SD | In distribution | |
| CS45-20-T | In distribution | |
| CP3-1L-19.5 | In distribution | |
| CP3-1L-27 | In distribution | |
| CS45-18-T | In distribution | |
| CP3-3L-49 | In distribution | |
| CP3-1L-22.5 | In distribution | |
| CP3-1L-21 | In distribution | |
| CP3S-V40-18 | In distribution | |
| CP3S-V45-12 | In distribution | |
| CP3-1L-25.5 | In distribution | |
| CP3-1L-24 | In distribution | |
| CP3-4L-73 | In distribution | |
| CP3-2L-45 | In distribution | |
| CP3-2L-35 | In distribution | |
| CP3-3L-57 | In distribution | |
| CS40-20-SD | In distribution | |
| CP3S-V40-22 | In distribution | |
| CP3-3L-65 | In distribution | |
| CP3S-V45-14 | In distribution | |
| CP3-4L-78 | In distribution | |
| CP3-2L-40 | In distribution | |
| CS40-14-SD | In distribution | |
| CS45-14-T | In distribution | |
| CP3-2L-50 | In distribution | |
| CS40-22-SD | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| ReLine | Nuvasive, Inc. | 2,998 |
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 2,568 |
| Creo | Globus Medical, Inc. | 1,765 |
| AccelFix Spinal Fixation System | L&K Biomed Co., Ltd. | 1,755 |
| Ozark Cervical Plate System | VB Spine LLC | 1,460 |
| Sirion | Astura Medical | 1,246 |
| Apex Spine System | Spinecraft LLC | 1,187 |
| AnyPlus Spinal Fixation System | GS Medical Co., Ltd. | 986 |
| Astra Spine System | Spinecraft LLC | 970 |
| Zavation | Zavation | 966 |
| ACP | Nuvasive, Inc. | 918 |
| Polaris™ 5.5 Spinal System | Biomet Spine | 877 |
Showing 12 of 855. All products under Appliance, Fixation, Spinal Intervertebral Body
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K231145 | 2023-06-13 |
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.