Rampart One Lumbar Interbody Fusion Device
The Rampart One Standard spacer supports lumbar interbody fusion at one or two adjacent levels from L2 to S1 in skeletally mature patients with degenerative disc disease. Patients may have…
The Rampart One Standard spacer supports lumbar interbody fusion at one or two adjacent levels from L2 to S1 in skeletally mature patients with degenerative disc disease. Patients may have up to Grade 1 spondylolisthesis and should have completed six months of nonoperative treatment.
The spacer combines HA enhanced PEEK, a titanium alloy faceplate and tantalum markers. Its hollow core holds bone graft, and the standard configuration accommodates four titanium alloy screws through the anterior faceplate into adjacent vertebrae.
Listed Item
Rampart One Standard Spacer
Graft and Supplemental Fixation
The system is used with autograft or allograft consisting of cancellous or corticocancellous bone and with supplemental lumbar fixation. Different heights and lordotic angles accommodate anatomy. The separate oblique configuration uses two screws rather than the standard four.
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) | K163670 |
| Record published | 2017-05-19 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Sterilisation | Radiation Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Sizes | Height 10.5 to 18 mm; length 15 to 30 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 10-10-76-15 | Height 14 mm | In distribution |
| 10-10-76-25 | Height 18 mm | In distribution |
| 10-10-76-2 | Height 10.5 mm | In distribution |
| 10-10-77-4 | Height 12 mm | In distribution |
| 10-10-76-14 | Height 14 mm | In distribution |
| 10-10-76-6 | Height 12 mm | In distribution |
| 10-10-75-8 | Length 30 mm | In distribution |
| 10-10-76-11 | Height 14 mm | In distribution |
| 10-10-76-17 | Height 16 mm | In distribution |
| 10-10-76-7 | Height 12 mm | In distribution |
| 10-10-75-6 | Length 20 mm | In distribution |
| 10-10-77-6 | Height 14 mm | In distribution |
| 10-10-76-8 | Height 12 mm | In distribution |
| 10-10-76-12 | Height 14 mm | In distribution |
| 10-10-76-23 | Height 18 mm | In distribution |
| 10-10-75-4 | Length 30 mm | In distribution |
| 10-10-77-8 | Height 16 mm | In distribution |
| 10-10-76-27 | Height 18 mm | In distribution |
| 10-10-77-7 | Height 16 mm | In distribution |
| 10-10-76-9 | Height 12 mm | In distribution |
| 10-10-76-13 | Height 14 mm | In distribution |
| 10-10-76-1 | Height 10.5 mm | In distribution |
| 10-10-76-26 | Height 18 mm | In distribution |
| 10-10-76-3 | Height 10.5 mm | In distribution |
| 10-10-76-10 | Height 14 mm | In distribution |
| 10-10-76-5 | Height 12 mm | In distribution |
| 10-10-77-5 | Height 14 mm | In distribution |
| 10-10-75-2 | Length 20 mm | In distribution |
| 10-10-77-3 | Height 12 mm | In distribution |
| 10-10-76-4 | Height 12 mm | In distribution |
| 10-10-76-20 | Height 16 mm | In distribution |
| 10-10-76-16 | Height 16 mm | In distribution |
| 10-10-77-1 | Height 10.5 mm | In distribution |
| 10-10-77-2 | Height 10.5 mm | In distribution |
| 10-10-75-5 | Length 15 mm | In distribution |
| 10-10-76-19 | Height 16 mm | In distribution |
| 10-10-75-7 | Length 25 mm | In distribution |
| 10-10-76-18 | Height 16 mm | In distribution |
| 10-10-75-1 | Length 15 mm | In distribution |
| 10-10-75-3 | Length 25 mm | In distribution |
| 10-10-76-22 | Height 18 mm | In distribution |
| 10-10-76-24 | Height 18 mm | In distribution |
| 10-10-76-21 | Height 16 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.