ProLift Lateral Fixated
ProLift Lateral Fixated is a titanium alloy interbody fusion implant range for supporting the space between vertebral bodies. Its interior accommodates autograft or cancellous or…
ProLift Lateral Fixated is a titanium alloy interbody fusion implant range for supporting the space between vertebral bodies. Its interior accommodates autograft or cancellous or corticocancellous allograft bone.
Teeth on the upper and lower surfaces help resist rotation and migration at the vertebral interface. Implant size and footprint vary, with fixed and variable screw configurations provided in the system.
Fixation Assembly
The implant may be used with two bone screws and requires additional supplemental spinal fixation. The cage, graft and fixation parts therefore have distinct roles within the lumbar fusion construct.
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 | Life Spine, United States |
|---|---|
| FDA product code | OVD |
| Device type | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K200338 |
| Record published | 2022-05-23 |
| Record revised | 2025-11-20 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Radiation Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 58-1860-0010LP | In distribution | |
| 58-1855-0010LP | In distribution | |
| 58-2245-0008LP | In distribution | |
| 58-1855-0710LP | In distribution | |
| 58-2250-0708LP | In distribution | |
| 58-1855-0708LP | In distribution | |
| 58-2245-1511LP | In distribution | |
| 58-2250-1511LP | In distribution | |
| 58-2255-1511LP | In distribution | |
| 58-1850-1510LP | In distribution | |
| 58-2250-0008LP | In distribution | |
| 58-1850-1512LP | In distribution | |
| 58-1850-0010LP | In distribution | |
| 58-1850-0008LP | In distribution | |
| 58-2255-0710LP | In distribution | |
| 58-1855-1512LP | In distribution | |
| 58-1845-0008LP | In distribution | |
| 58-2250-1513LP | In distribution | |
| 58-1860-1510LP | In distribution | |
| 58-2260-1511LP | In distribution | |
| 58-2250-0010LP | In distribution | |
| 58-1850-0708LP | In distribution | |
| 58-2255-1513LP | In distribution | |
| 58-2260-1513LP | In distribution | |
| 58-1845-0010LP | In distribution | |
| 58-1860-1512LP | In distribution | |
| 58-1845-1512LP | In distribution | |
| 58-1860-0708LP | In distribution | |
| 58-2255-0010LP | In distribution | |
| 58-2245-1513LP | In distribution | |
| 58-2250-0710LP | In distribution | |
| 58-2260-0010LP | In distribution | |
| 58-1855-1510LP | In distribution | |
| 58-1845-0708LP | In distribution | |
| 58-1845-0710LP | In distribution | |
| 58-2260-0008LP | In distribution | |
| 58-2245-0708LP | In distribution | |
| 58-2245-0710LP | In distribution | |
| 58-2260-0710LP | In distribution | |
| 58-1860-0710LP | In distribution | |
| 58-2260-0708LP | In distribution | |
| 58-1855-0008LP | In distribution | |
| 58-1845-1510LP | In distribution | |
| 58-2245-0010LP | In distribution | |
| 58-1860-0008LP | In distribution | |
| 58-2255-0708LP | In distribution | |
| 58-2255-0008LP | 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 |
|---|---|
| K200338 | 2020-04-17 |
| K191834 | 2019-12-16 |
| K180215 | 2018-09-13 |
| K091301 | 2009-12-15 |
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.