Rampart One Lumbar Interbody Fusion System
Rampart One combines an HA-enhanced PEEK spacer, titanium-alloy face plate, tantalum markers and integrated titanium-alloy screws. Its hollow core holds autograft or specified allograft…
Rampart One combines an HA-enhanced PEEK spacer, titanium-alloy face plate, tantalum markers and integrated titanium-alloy screws. Its hollow core holds autograft or specified allograft while the device stabilizes the lumbar interbody space.
Standard configurations accommodate four screws, while oblique configurations accommodate two. The screws pass through the anterior face plate into adjacent vertebral bodies.
Listed Item
Rampart One Standard Spacer, 14mm, S, 16°
Lordosis and Supplemental Fixation
Standard 8-degree and 12-degree devices can be used without supplemental fixation when all four screws are used. Standard 16-degree and 20-degree devices require four screws plus supplemental fixation. Oblique devices require two screws and supplemental fixation. These constructs support one or two contiguous levels from L2 to S1.
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 | Spineology 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 | Manufacturer |
| 510(k) | K192047 |
| Record published | 2025-04-21 |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Sizes | Height 10.5 to 18 mm; angle 8 to 20 °; length 28 cm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 102-63-06-15 | Height 16 mm | In distribution |
| 49-02-01-25 | Height 14 mm | In distribution |
| 102-63-06-14 | Height 14 mm | In distribution |
| 10-10-76-29 | 16° Lordosis | In distribution |
| 10-10-76-28 | Height 14 mm | In distribution |
| 10-10-76-36 | 16° Lordosis | In distribution |
| 102-63-06-16 | Height 12 mm | In distribution |
| 102-63-06-21 | Height 16 mm | In distribution |
| 49-02-01-31 | Height 16 mm | In distribution |
| 49-12-10 | Height 10.5 mm | In distribution |
| 49-02-01-17 | Height 16 mm | In distribution |
| 102-63-02 | In distribution | |
| 49-10-40 | In distribution | |
| 49-02-01-6 | Small Footprint | In distribution |
| 102-63-01-2 | In distribution | |
| 10-10-76-41 | Height 18 mm | In distribution |
| 49-22-01-7 | Medium Footprint | In distribution |
| 102-63-06-24 | Height 18 mm | In distribution |
| 49-22-01-8 | Height 16 mm | In distribution |
| 49-02-01-1 | Small Footprint | In distribution |
| 10-10-76-39 | Height 18 mm | In distribution |
| 10-10-76-34 | Height 16 mm | In distribution |
| 49-02-01-2 | Height 12 mm | In distribution |
| 49-02-01-29 | Height 14 mm | In distribution |
| 102-63-06-4 | Height 12 mm | In distribution |
| 49-12-12 | Height 14 mm | In distribution |
| 49-12-11 | Height 12 mm | In distribution |
| 49-02-01-3 | Small Footprint | In distribution |
| 10-10-76-37 | Height 16 mm | In distribution |
| 102-63-06-5 | Height 14 mm | In distribution |
| 49-02-01-24 | Large Footprint | In distribution |
| 102-63-06-3 | Height 14 mm | In distribution |
| 10-10-76-32 | Height 16 mm | In distribution |
| 102-63-06-23 | Height 18 mm | In distribution |
| 102-63-01-1 | In distribution | |
| 49-02-01-15 | Height 12 mm | In distribution |
| 102-63-06-8 | Height 14 mm | In distribution |
| 10-10-76-40 | 20° Lordosis | In distribution |
| 102-63-06-22 | Height 16 mm | In distribution |
| 102-63-06-1 | Height 10.5 mm | In distribution |
| 49-02-01-7 | Height 14 mm | In distribution |
| 49-02-01-20 | Height 12 mm | In distribution |
| 49-02-01-16 | Medium Footprint | In distribution |
| 49-02-01-32 | Height 18 mm | In distribution |
| 49-02-01-12 | Height 14 mm | In distribution |
| 10-10-76-31 | 16° Lordosis | In distribution |
| 102-63-06-19 | Height 18 mm | In distribution |
| 102-63-06-18 | Height 16 mm | In distribution |
| 49-12-16 | Height 18 mm | In distribution |
| 49-02-01-11 | Medium Footprint | In distribution |
| 49-02-01-10 | Height 10.5 mm | In distribution |
| 102-63-06-12 | Height 16 mm | In distribution |
| 102-63-06-13 | Height 12 mm | In distribution |
| 102-63-06-6 | Height 10.5 mm | In distribution |
| 49-02-01-13 | Medium Footprint | In distribution |
| 49-12-14 | In distribution | |
| 10-10-76-30 | Height 14 mm | In distribution |
| 49-22-01-5 | Medium Footprint | In distribution |
| 49-28-01 | In distribution | |
| 49-02-01-33 | 20° Lordosis | In distribution |
| 102-53-01 | Length 28 cm | In distribution |
| 102-63-06-11 | Height 14 mm | In distribution |
| 49-22-01-6 | Height 12 mm | In distribution |
| 102-63-06-2 | Height 12 mm | In distribution |
| 49-02-01-22 | Height 16 mm | In distribution |
| 10-10-76-38 | 16° Lordosis | In distribution |
| 49-02-01-21 | Large Footprint | In distribution |
| 10-10-76-35 | 20° Lordosis | In distribution |
| 49-12-13 | Height 16 mm | In distribution |
| 49-02-01-30 | 16° Lordosis | In distribution |
| 10-10-76-42 | 16° Lordosis | In distribution |
| 49-22-01-1 | Height 10.5 mm | In distribution |
| 102-63-06-17 | Height 14 mm | In distribution |
| 102-63-06-10 | Height 12 mm | In distribution |
| 102-63-06-9 | Height 16 mm | In distribution |
| 102-63-06-7 | Height 12 mm | In distribution |
| 49-22-01-2 | Small Footprint | In distribution |
| 10-10-76-33 | 20° Lordosis | In distribution |
| 49-02-01-34 | 12° Lordosis | In distribution |
| 49-02-01-26 | Large Footprint | In distribution |
| 49-02-02 | In distribution | |
| 10-10-76-43 | Height 18 mm | In distribution |
| 49-22-01-3 | Height 14 mm | In distribution |
| 102-63-06-20 | Height 14 mm | 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 |
|---|---|
| K192047 | 2019-08-23 |
| K191091 | 2019-05-23 |
| K180002 | 2018-04-25 |
| K163670 | 2017-05-08 |
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.