Brisbane Alif Cage
The Brisbane ALIF Cage supports lumbar interbody fusion using autogenous bone graft in skeletally mature patients with degenerative disc disease at one or two adjacent levels from L2 to S1.…
The Brisbane ALIF Cage supports lumbar interbody fusion using autogenous bone graft in skeletally mature patients with degenerative disc disease at one or two adjacent levels from L2 to S1. Patients may have up to Grade I spondylolisthesis or retrolisthesis and must have completed six months of nonoperative treatment.
The wedge-shaped PEEK cage has a hollow graft space and serrated upper and lower surfaces. Titanium plasma spray coats those surfaces. It is placed through an open or laparoscopic anterior approach, and its wedge geometry supports lordosis of the fused vertebral bodies.
Fixation
Three anterior holes accept titanium alloy bone screws. When used as a standalone device, all three screws are required. The system may also be used with supplemental fixation.
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 | Signature Orthopaedics PTY Limited, Australia |
|---|---|
| FDA product code | OVD |
| Device type | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K172019 |
| Record published | 2018-01-10 |
| Record revised | 2025-07-21 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PS1-23-1087 | In distribution | |
| PS1-23-1085 | In distribution | |
| PS1-23-3167 | In distribution | |
| PS1-23-2125 | In distribution | |
| PS1-23-3165 | In distribution | |
| PS1-23-5163 | In distribution | |
| PS1-23-5083 | In distribution | |
| PS1-23-5125 | In distribution | |
| PS1-23-5121 | In distribution | |
| PS1-23-2163 | In distribution | |
| PS1-23-1167 | In distribution | |
| PS1-23-3121 | In distribution | |
| PS1-23-2121 | In distribution | |
| PS1-23-1123 | In distribution | |
| PS1-23-1121 | In distribution | |
| PS1-23-4161 | In distribution | |
| PS1-23-4167 | In distribution | |
| PS1-23-3127 | In distribution | |
| PS1-23-4127 | In distribution | |
| PS1-23-1083 | In distribution | |
| PS1-23-2167 | In distribution | |
| PS1-23-4085 | In distribution | |
| PS1-23-5127 | In distribution | |
| PS1-23-2161 | In distribution | |
| PS1-23-3163 | In distribution | |
| PS1-23-1161 | In distribution | |
| PS1-23-5085 | In distribution | |
| PS1-23-4121 | In distribution | |
| PS1-23-5165 | In distribution | |
| PS1-23-5087 | In distribution | |
| PS1-23-2081 | In distribution | |
| PS1-23-5167 | In distribution | |
| PS1-23-3125 | In distribution | |
| PS1-23-2085 | In distribution | |
| PS1-23-3123 | In distribution | |
| PS1-23-4165 | In distribution | |
| PS1-23-1127 | In distribution | |
| PS1-23-2087 | In distribution | |
| PS1-23-3161 | In distribution | |
| PS1-23-3087 | In distribution | |
| PS1-23-1163 | In distribution | |
| PS1-23-5123 | In distribution | |
| PS1-23-1081 | In distribution | |
| PS1-23-2083 | In distribution | |
| PS1-23-3085 | In distribution | |
| PS1-23-4081 | In distribution | |
| PS1-23-4163 | In distribution | |
| PS1-23-2123 | In distribution | |
| PS1-23-3081 | In distribution | |
| PS1-23-4083 | In distribution | |
| PS1-23-5161 | In distribution | |
| PS1-23-3083 | In distribution | |
| PS1-23-2165 | In distribution | |
| PS1-23-1165 | In distribution | |
| PS1-23-4087 | In distribution | |
| PS1-23-1125 | In distribution | |
| PS1-23-5081 | In distribution | |
| PS1-23-4125 | In distribution | |
| PS1-23-4123 | In distribution | |
| PS1-23-2127 | 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 |
|---|---|
| K172019 | 2017-11-29 |
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.