Axis Spine Technologies Alif Implant
Superior Endplate Hyper Lordotic (10) - Medium
3manufacturers in China registered for this device type
63catalogue numbers in this listing
2510(k) clearances naming this product code
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 |
| Record published | 2024-05-23 |
| Record revised | 2025-12-17 (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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1984-52-275 | In distribution | |
| 1984-00-111 | In distribution | |
| 1984-52-300 | In distribution | |
| 1984-00-350 | In distribution | |
| 1984-00-115 | In distribution | |
| 1984-08-150 | In distribution | |
| 1984-10-100 | In distribution | |
| 1984-08-030 | In distribution | |
| 1984-52-225 | In distribution | |
| 1984-52-325 | In distribution | |
| 1984-00-155 | In distribution | |
| 1984-00-150 | In distribution | |
| 1984-08-015 | In distribution | |
| 1984-00-110 | In distribution | |
| 1984-52-350 | In distribution | |
| 1984-06-025 | In distribution | |
| 1984-42-350 | In distribution | |
| 1984-00-300 | In distribution | |
| 1984-00-200 | In distribution | |
| 1984-42-200 | In distribution | |
| 1984-00-311 | In distribution | |
| 1984-00-405 | In distribution | |
| 1984-08-200 | In distribution | |
| 1984-10-020 | In distribution | |
| 1984-00-105 | In distribution | |
| 1984-52-250 | In distribution | |
| 1984-00-100 | In distribution | |
| 1984-06-150 | In distribution | |
| 1984-00-310 | In distribution | |
| 1984-06-010 | In distribution | |
| 1984-00-205 | In distribution | |
| 1984-42-250 | In distribution | |
| 1984-08-010 | In distribution | |
| 1984-06-250 | In distribution | |
| 1984-00-255 | In distribution | |
| 1984-00-355 | In distribution | |
| 1984-00-375 | In distribution | |
| 1984-06-030 | In distribution | |
| 1984-08-020 | In distribution | |
| 1984-00-250 | In distribution | |
| 1984-10-010 | In distribution | |
| 1984-42-325 | In distribution | |
| 1984-06-020 | In distribution | |
| 1984-06-015 | In distribution | |
| 1984-06-300 | In distribution | |
| 1984-10-200 | In distribution | |
| 1984-10-150 | In distribution | |
| 1984-00-305 | In distribution | |
| 1984-08-025 | In distribution | |
| 1984-00-175 | In distribution | |
| 1984-08-250 | In distribution | |
| 1984-06-100 | In distribution | |
| 1984-06-200 | In distribution | |
| 1984-00-400 | In distribution | |
| 1984-00-315 | In distribution | |
| 1984-42-275 | In distribution | |
| 1984-00-450 | In distribution | |
| 1984-52-200 | In distribution | |
| 1984-00-455 | In distribution | |
| 1984-42-300 | In distribution | |
| 1984-10-015 | In distribution | |
| 1984-08-300 | In distribution | |
| 1984-08-100 | 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.