Axis Spine Technologies Alif
Axis Spine Technologies ALIF is a modular anterior lumbar interbody system assembled inside the disc space. Two titanium-alloy endplates and a central core form the spacer, with shapes and…
Axis Spine Technologies ALIF is a modular anterior lumbar interbody system assembled inside the disc space. Two titanium-alloy endplates and a central core form the spacer, with shapes and sizes selected for the reconstruction.
The hollow core accepts autogenous and/or allogeneic bone graft. Rough endplate surfaces engage the adjacent vertebrae to resist migration.
Listed Item
Endplate Superior Large Double Taper Coronal Right 10°
Components and Fixation
The construct also includes three titanium-alloy bone screws and a PEEK-OPTIMA HA Enhanced cover plate. Supplemental internal spinal fixation, such as a posterior pedicle-screw and rod system, is required alongside the interbody device.
Who Else Makes It
Concentrated in Shandong (2), Jiangsu (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
Record
| Listed by | Axis Spine Technologies Ltd, United Kingdom |
|---|---|
| FDA product code | OVD |
| Device type | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| Establishment | Remanufacturer, Reprocessor, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K200352 |
| Record published | 2021-02-09 |
| Record revised | 2025-12-17 (version 4) |
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 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| A5240325 | In distribution | |
| A6090100 | In distribution | |
| 1984-00-321 | In distribution | |
| A1311210 | In distribution | |
| A1311110 | In distribution | |
| A3210200 | In distribution | |
| A6040000 | In distribution | |
| 1984-00-465 | In distribution | |
| A6020000 | In distribution | |
| A1313110 | In distribution | |
| 1984-00-360 | In distribution | |
| A6080100 | In distribution | |
| A6061015 | In distribution | |
| A6080500 | In distribution | |
| A2511210 | In distribution | |
| A4210150 | In distribution | |
| 1984-00-420 | In distribution | |
| A5140300 | In distribution | |
| A6070300 | In distribution | |
| A6060630 | In distribution | |
| A1511120 | In distribution | |
| A2511110 | In distribution | |
| A6060625 | In distribution | |
| A6120300 | In distribution | |
| A6060615 | In distribution | |
| A6200400 | In distribution | |
| 1984-00-385 | In distribution | |
| A4206250 | In distribution | |
| A6061010 | In distribution | |
| A6060815 | In distribution | |
| A5140275 | In distribution | |
| A3210150 | In distribution | |
| A3206150 | In distribution | |
| A3208100 | In distribution | |
| A2513110 | In distribution | |
| A5240250 | In distribution | |
| A4206150 | In distribution | |
| A4206300 | In distribution | |
| A6090200 | In distribution | |
| A3206200 | In distribution | |
| A6060830 | In distribution | |
| 1984-00-421 | In distribution | |
| A5140350 | In distribution | |
| A2511120 | In distribution | |
| A3206300 | In distribution | |
| A6120100 | In distribution | |
| A5240275 | In distribution | |
| A2311110 | In distribution | |
| A3206250 | In distribution | |
| A4208100 | In distribution | |
| A4206100 | In distribution | |
| A1513110 | In distribution | |
| A3206100 | In distribution | |
| A3208250 | In distribution | |
| A4208250 | In distribution | |
| A3210100 | In distribution | |
| A1311120 | In distribution | |
| A6060825 | In distribution | |
| 1984-00-320 | In distribution | |
| A3208150 | In distribution | |
| A2313110 | In distribution | |
| A1511110 | In distribution | |
| A6060810 | In distribution | |
| A4208150 | In distribution | |
| A2311120 | In distribution | |
| A3208200 | In distribution | |
| A6060820 | In distribution | |
| A5240300 | In distribution | |
| A3208300 | In distribution | |
| A2311210 | In distribution | |
| A1511210 | In distribution | |
| A6061020 | In distribution | |
| A4210200 | In distribution | |
| A4210100 | In distribution | |
| 1984-00-365 | In distribution | |
| A4206200 | In distribution | |
| 1984-00-460 | In distribution | |
| A5140250 | In distribution | |
| A5140325 | In distribution | |
| A4208300 | In distribution | |
| A6060620 | In distribution | |
| A6160100 | In distribution | |
| A6060610 | In distribution | |
| A4208200 | In distribution | |
| A6120200 | In distribution | |
| A5240350 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Sirion | Astura Medical | 1,465 |
| IdentiTi | Alphatec Spine, Inc. | 1,372 |
| EL Capitan | Astura Medical | 1,205 |
| Zavation | Zavation | 1,157 |
| Brigade | Nuvasive, Inc. | 1,005 |
| Solar™ Interbody Fusion System | Degen Medical | 899 |
| Zavation F3D Corpectomy | Zavation | 730 |
| ROI-A | Ldr Spine USA | 552 |
| Avenue L | Ldr Spine USA | 524 |
| Transcend Nanotec | Alphatec Spine, Inc. | 485 |
| Endoskeleton® TL Hyperlordotic nanoLOCK® Surface Technology | Titan Spine, LLC | 462 |
| Base | Nuvasive, Inc. | 462 |
Showing 12 of 241. All products under Intervertebral Fusion Device With Integrated Fixation, Lumbar
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K210590 | 2021-09-29 |
| K200352 | 2020-05-20 |
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.