Axis Spine Technologies Alif System Instrument
Sterilisation Case - Auxiliary Instruments
3manufacturers in China registered for this device type
126catalogue 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 | 2023-05-17 |
| 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 |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| A6201260 | In distribution | |
| 2984 00 130 | In distribution | |
| 2984 00 400 | In distribution | |
| A6202250 | In distribution | |
| GI-9015 | In distribution | |
| A6201600 | In distribution | |
| A6200106 | In distribution | |
| AI-4011 | In distribution | |
| A6201700 | In distribution | |
| AI-4000.3 | In distribution | |
| A6060670 | In distribution | |
| A6061060 | In distribution | |
| AI6030.2 | In distribution | |
| A6202450 | In distribution | |
| A6204040 | In distribution | |
| A6170100 | In distribution | |
| 2984 00 300 | In distribution | |
| A6200300 | In distribution | |
| AI-6012.2 | In distribution | |
| A6060865 | In distribution | |
| AI-4000.2 | In distribution | |
| A6200110 | In distribution | |
| AI-4625 | In distribution | |
| A6202655 | In distribution | |
| A6202800 | In distribution | |
| A6060870 | In distribution | |
| A6204020 | In distribution | |
| AI-4630 | In distribution | |
| AI-6010.1 | In distribution | |
| AI-4810 | In distribution | |
| A6060680 | In distribution | |
| A6200525 | In distribution | |
| A6100000 | In distribution | |
| A6170200 | In distribution | |
| A6200112 | In distribution | |
| A6060665 | In distribution | |
| A6061065 | In distribution | |
| 2984 30 310 | In distribution | |
| 2984 00 115 | In distribution | |
| AI6030.3 | In distribution | |
| AI-4615 | In distribution | |
| A6204025 | In distribution | |
| A6060660 | In distribution | |
| 2984 40 610 | In distribution | |
| A6200550 | In distribution | |
| A6200350 | In distribution | |
| A6204035 | In distribution | |
| AI-5025.1 | In distribution | |
| AI-4010 | In distribution | |
| 2984 00 210 | In distribution | |
| A6201800 | In distribution | |
| 2984 00 310 | In distribution | |
| A6205700 | In distribution | |
| 2984 00 200 | In distribution | |
| GI-9025 | In distribution | |
| AI6030.1 | In distribution | |
| 2984 40 500 | In distribution | |
| AI-6012.1 | In distribution | |
| AI-4050.2 | In distribution | |
| A6204045 | In distribution | |
| A6200325 | In distribution | |
| A6060880 | In distribution | |
| AI-4030 | In distribution | |
| A6201270 | In distribution | |
| 2984 30 500 | In distribution | |
| A6020200 | In distribution | |
| A6060675 | In distribution | |
| A6202400 | In distribution | |
| A6130000 | In distribution | |
| A6204000 | In distribution | |
| A6201950 | In distribution | |
| AI-6010.2 | In distribution | |
| A6204030 | In distribution | |
| A6201810 | In distribution | |
| AI-4820 | In distribution | |
| A6060860 | In distribution | |
| AI-4020 | In distribution | |
| A6201610 | In distribution | |
| A6202050 | In distribution | |
| AI-4120 | In distribution | |
| AI-4115 | In distribution | |
| AI-4050.1 | In distribution | |
| A6204044 | In distribution | |
| AI-4830 | In distribution | |
| AI-4815 | In distribution | |
| A6201550 | In distribution | |
| AI-5025.2 | In distribution | |
| A6020450 | In distribution | |
| AI-4610 | In distribution | |
| A6020050 | In distribution | |
| A6201710 | In distribution | |
| A6090201 | In distribution | |
| 2984 40 600 | In distribution | |
| A6020400 | In distribution | |
| A6061070 | In distribution | |
| GI-9010 | In distribution | |
| AI-4000.1 | In distribution | |
| A6202650 | In distribution | |
| AI-4110 | In distribution | |
| GI-9020 | In distribution | |
| AI-4620 | In distribution | |
| AI-4825 | In distribution | |
| A6201450 | In distribution | |
| A6204024 | In distribution | |
| AI-6011 | In distribution | |
| 2984 00 125 | In distribution | |
| AI-5027.1 | In distribution | |
| A6201475 | In distribution | |
| 2984 00 550 | In distribution | |
| A6200500 | In distribution | |
| A6200108 | In distribution | |
| A6200375 | In distribution | |
| A6206000 | In distribution | |
| 2984 00 120 | In distribution | |
| 2984 30 210 | In distribution | |
| 2984 00 100 | In distribution | |
| 2984 00 000 | In distribution | |
| A6204034 | In distribution | |
| 2984 00 135 | In distribution | |
| A6020250 | In distribution | |
| 2984 00 500 | In distribution | |
| 2984 00 110 | In distribution | |
| A6020150 | In distribution | |
| A6060875 | In distribution | |
| A6100100 | In distribution | |
| AI-5027.2 | 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.