ProAM Alif System
ProAM ALIF is a titanium alloy interbody fusion system placed between vertebrae in the lumbar or lumbosacral spine. Its box-shaped cage has bone graft cavities, an open porous architecture…
ProAM ALIF is a titanium alloy interbody fusion system placed between vertebrae in the lumbar or lumbosacral spine. Its box-shaped cage has bone graft cavities, an open porous architecture and textured porous surfaces where it contacts the vertebral endplates.
Integrated titanium alloy screws pass through the cage into the adjacent vertebral bodies. Direct anterior cages have two or three screw holes; oblique-anterior configurations have two. Footprint, height and lordotic angle vary with the selected implant.
Listed Item
Fixated ALIF 3-Hole – 34mm x 25mm x 12mm, 30°
Fixation Requirements
The system is used with bone graft. Three-screw implants with a lordotic angle of 20° or less may be used without supplemental fixation for specified one- or two-level applications. Implants above 20°, two-screw configurations and specified multilevel or deformity applications require supplemental spinal fixation in addition to the integrated screws.
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 | PRO Surgical, Inc., 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, Complaint-file establishment, Manufacturer |
| 510(k) | K240126 |
| Record published | 2025-01-16 |
| Record revised | 2025-07-14 (version 2) |
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, manufacturing date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| LN-033425-3012 | In distribution | |
| LN-033827-0618 | In distribution | |
| LN-033827-3010 | In distribution | |
| LN-033827-0612 | In distribution | |
| LN-033425-2414 | In distribution | |
| LN-033425-0618 | In distribution | |
| LN-033425-0612 | In distribution | |
| LN-034229-3020 | In distribution | |
| LN-034229-0610 | In distribution | |
| LN-033425-3014 | In distribution | |
| LN-034229-3018 | In distribution | |
| LN-033425-1212 | In distribution | |
| LN-033827-1820 | In distribution | |
| LN-034229-1814 | In distribution | |
| LN-034229-1810 | In distribution | |
| LN-034229-0612 | In distribution | |
| LN-033425-2410 | In distribution | |
| LN-010050-0020 | In distribution | |
| LN-033425-3016 | In distribution | |
| LN-034229-1216 | In distribution | |
| LN-034229-3012 | In distribution | |
| LN-033425-1810 | In distribution | |
| LN-034229-1818 | In distribution | |
| LN-034229-2418 | In distribution | |
| LN-010050-0035 | In distribution | |
| LN-034229-2420 | In distribution | |
| LN-010610-0000 | In distribution | |
| LN-010055-0020 | In distribution | |
| LN-033425-0610 | In distribution | |
| LN-033425-3010 | In distribution | |
| LN-033827-0620 | In distribution | |
| LN-033827-1214 | In distribution | |
| LN-033425-1816 | In distribution | |
| LN-033425-1210 | In distribution | |
| LN-010155-0030 | In distribution | |
| LN-033827-1812 | In distribution | |
| LN-033827-3012 | In distribution | |
| LN-033827-0614 | In distribution | |
| LN-033827-1220 | In distribution | |
| LN-033827-3014 | In distribution | |
| LN-033425-0614 | In distribution | |
| LN-033827-0616 | In distribution | |
| LN-010055-0035 | In distribution | |
| LN-010605-0000 | In distribution | |
| LN-033827-1212 | In distribution | |
| LN-034229-0616 | In distribution | |
| LN-033425-1220 | In distribution | |
| LN-034229-2412 | In distribution | |
| LN-033827-2410 | In distribution | |
| LN-033827-1816 | In distribution | |
| LN-033425-1812 | In distribution | |
| LN-033425-1218 | In distribution | |
| LN-033425-1814 | In distribution | |
| LN-033425-2416 | In distribution | |
| LN-033425-1818 | In distribution | |
| LN-034229-3014 | In distribution | |
| LN-034229-3016 | In distribution | |
| LN-033425-1216 | In distribution | |
| LN-033425-0616 | In distribution | |
| LN-034229-3010 | In distribution | |
| LN-034229-1220 | In distribution | |
| LN-034229-1816 | In distribution | |
| LN-033425-2418 | In distribution | |
| LN-034229-2416 | In distribution | |
| LN-034229-0614 | In distribution | |
| LN-034229-0618 | In distribution | |
| LN-034229-1214 | In distribution | |
| LN-010055-0030 | In distribution | |
| LN-033425-2412 | In distribution | |
| LN-034229-2410 | In distribution | |
| LN-033425-1820 | In distribution | |
| LN-033827-3016 | In distribution | |
| LN-010055-0025 | In distribution | |
| LN-033425-3018 | In distribution | |
| LN-033425-0620 | In distribution | |
| LN-010050-0025 | In distribution | |
| LN-033827-1216 | In distribution | |
| LN-033827-1818 | In distribution | |
| LN-010050-0030 | In distribution | |
| LN-034229-1820 | In distribution | |
| LN-034229-1212 | In distribution | |
| LN-010155-0025 | In distribution | |
| LN-010155-0020 | In distribution | |
| LN-033827-1810 | In distribution | |
| LN-034229-2414 | In distribution | |
| LN-033827-2412 | In distribution | |
| LN-033827-3018 | In distribution | |
| LN-033827-2418 | In distribution | |
| LN-033827-2416 | In distribution | |
| LN-033827-1218 | In distribution | |
| LN-034229-1210 | In distribution | |
| LN-033425-1214 | In distribution | |
| LN-033827-1210 | In distribution | |
| LN-034229-1218 | In distribution | |
| LN-033425-3020 | In distribution | |
| LN-033827-2420 | In distribution | |
| LN-033827-3020 | In distribution | |
| LN-033827-0610 | In distribution | |
| LN-033425-2420 | In distribution | |
| LN-034229-0620 | In distribution | |
| LN-033827-1814 | In distribution | |
| LN-033827-2414 | In distribution | |
| LN-034229-1812 | 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 |
|---|---|
| K251644 | 2025-06-24 |
| K240126 | 2024-05-03 |
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.