Gladstone Alif Cage
The Gladstone ALIF Cage is an interbody implant placed through an anterior approach to support lumbar fusion. Its hollow center holds autogenous bone graft, and its wedge shape and serrated…
The Gladstone ALIF Cage is an interbody implant placed through an anterior approach to support lumbar fusion. Its hollow center holds autogenous bone graft, and its wedge shape and serrated upper and lower surfaces provide the implant geometry and resistance to expulsion.
It is made from PEEK-OPTIMA LT1 and has three anterior holes for titanium alloy bone screws. It may be used with supplemental fixation; stand-alone use requires all three screws.
Patient and Level Restrictions
The system is intended for skeletally mature patients with degenerative disc disease at one or two contiguous levels from L2 to S1 after six months of nonoperative treatment. Up to Grade I spondylolisthesis or retrolisthesis at the treated levels is included.
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 | 2018-07-06 (version 3) |
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 |
|---|---|---|
| PS1-01-0126 | In distribution | |
| PS1-01-0014 | In distribution | |
| PS1-01-0338 | In distribution | |
| PS1-01-0018 | In distribution | |
| PS1-01-0212 | In distribution | |
| PS1-01-0324 | In distribution | |
| PS1-01-0416 | In distribution | |
| PS1-01-0138 | In distribution | |
| PS1-01-0528 | In distribution | |
| PS1-01-0114 | In distribution | |
| PS1-01-0236 | In distribution | |
| PS1-01-0414 | In distribution | |
| PS1-01-0412 | In distribution | |
| PS1-01-0326 | In distribution | |
| PS1-01-0314 | In distribution | |
| PS1-01-0016 | In distribution | |
| PS1-01-0426 | In distribution | |
| PS1-01-0116 | In distribution | |
| PS1-01-0222 | In distribution | |
| PS1-01-0226 | In distribution | |
| PS1-01-0336 | In distribution | |
| PS1-01-0022 | In distribution | |
| PS1-01-0438 | In distribution | |
| PS1-01-0214 | In distribution | |
| PS1-01-0328 | In distribution | |
| PS1-01-0134 | In distribution | |
| PS1-01-0422 | In distribution | |
| PS1-01-0424 | In distribution | |
| PS1-01-0310 | In distribution | |
| PS1-01-0026 | In distribution | |
| PS1-01-0118 | In distribution | |
| PS1-01-0410 | In distribution | |
| PS1-01-0418 | In distribution | |
| PS1-01-0038 | In distribution | |
| PS1-01-0034 | In distribution | |
| PS1-01-0428 | In distribution | |
| PS1-01-0136 | In distribution | |
| PS1-01-0112 | In distribution | |
| PS1-01-0122 | In distribution | |
| PS1-01-0322 | In distribution | |
| PS1-01-0334 | In distribution | |
| PS1-01-0024 | In distribution | |
| PS1-01-0436 | In distribution | |
| PS1-01-0012 | In distribution | |
| PS1-01-0128 | In distribution | |
| PS1-01-0036 | In distribution | |
| PS1-01-0526 | In distribution | |
| PS1-01-0210 | In distribution | |
| PS1-01-0110 | In distribution | |
| PS1-01-0524 | In distribution | |
| PS1-01-0124 | In distribution | |
| PS1-01-0224 | In distribution | |
| PS1-01-0228 | In distribution | |
| PS1-01-0028 | In distribution | |
| PS1-01-0218 | In distribution | |
| PS1-01-0238 | In distribution | |
| PS1-01-0318 | In distribution | |
| PS1-01-0316 | In distribution | |
| PS1-01-0010 | In distribution | |
| PS1-01-0312 | In distribution | |
| PS1-01-0216 | 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.