Rampart-O
Rampart O belongs to a lumbar interbody fusion family with graft-holding implants and placement instruments. The implants provide mechanical stabilization within the disc space while fusion…
Rampart O belongs to a lumbar interbody fusion family with graft-holding implants and placement instruments. The implants provide mechanical stabilization within the disc space while fusion develops.
The cage body is PEEK-OPTIMA LT1 with titanium or tantalum markers. Its hollow core receives autograft or specified allograft, with configurations and heights varying across Rampart O, T and A designs.
Inserter and Fixation
An insertion instrument allows the implant to be positioned and manipulated in the intervertebral space; a listed implant inserter belongs to this tool group. The implants are intended for one or two contiguous levels from L2 to S1 with supplemental lumbar fixation.
14manufacturers in China registered for this device type
171catalogue numbers in this listing
22510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (6), Shandong (2), Shanghai (2). 7 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Suzhou Ahno Medical Devices Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 17 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Jiangsu Ideal Medical Science & Technology Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 7 |
| Zhisu Health Tech Jiaxing Co., Ltd. | Tongxiang | Zhejiang | Contract manufacturer | 4 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Shanghai Reach Medical Instrument Co., Ltd. | Shanghai | Shanghai | Manufacturer | 30 |
| Changzhou Geasure Medical Apparatus AND Instruments Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 25 |
| Double Medical Technology Inc. | Xiamen | Fujian | Contract manufacturer | 14 |
| Zhejiang Decans Medical Devices Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 10 |
Showing 12 of 14. All 14 manufacturers in China registered for Intervertebral Fusion Device With Bone Graft, Lumbar
Record
| Listed by | Spineology Inc., United States |
|---|---|
| FDA product code | MAX |
| Device type | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| Establishment | Manufacturer |
| 510(k) | K160906 |
| Record published | 2015-09-04 |
| Record revised | 2018-03-29 (version 2) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Sizes | Length 7 to 16 mm; height 7 to 16 mm |
| Distribution end date | 2015-09-18 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 83-02-10-14 | 14×30 | In distribution |
| 83-02-14-12 | 12×40 | In distribution |
| 83-04-07-41 | 11x40mm Trial | In distribution |
| 83-02-20-9 | 9×25 | In distribution |
| 83-02-18-12 | Length 12 mm | In distribution |
| 83-02-16-12 | 12×25 | In distribution |
| 83-02-16-8 | Length 8 mm | In distribution |
| 83-02-18-11 | 11×30 | In distribution |
| 83-02-44-16 | Length 16 mm | In distribution |
| 83-02-12-10 | Length 10 mm | In distribution |
| 83-02-18-16 | Length 16 mm | In distribution |
| 10-10-41-20 | Length 16 mm | In distribution |
| 83-04-07-8 | 8x25mm Trial | In distribution |
| 83-04-07-15 | Height 15 mm | In distribution |
| 83-02-42-13 | Length 13 mm | In distribution |
| 10-10-41-26 | 12×35 | In distribution |
| 83-02-20-8 | 8×25 | In distribution |
| 83-02-10-10 | 10×30 | In distribution |
| 83-02-16-16 | 16×25 | In distribution |
| 10-10-41-19 | Length 15 mm | In distribution |
| 83-02-14-7 | 7×40 | In distribution |
| 83-02-10-12 | 12×30 | In distribution |
| 10-10-41-29 | Length 15 mm | In distribution |
| 83-04-07-38 | Height 8 mm | In distribution |
| 83-04-07-43 | Height 13 mm | In distribution |
| 10-10-41-27 | Length 13 mm | In distribution |
| 10-10-41-39 | 15×40 | In distribution |
| 10-10-41-13 | 9×30 | In distribution |
| 83-02-16-14 | Length 14 mm | In distribution |
| 83-02-44-13 | Length 13 mm | In distribution |
| 83-02-42-14 | 14×35 | In distribution |
| 83-04-07-16 | Height 16 mm | In distribution |
| 83-04-07-46 | 16x40mm Trial | In distribution |
| 83-02-44-8 | Length 8 mm | In distribution |
| 10-10-41-30 | Length 16 mm | In distribution |
| 83-02-20-12 | 12×25 | In distribution |
| 83-02-42-15 | Length 15 mm | In distribution |
| 83-02-16-11 | 11×25 | In distribution |
| 10-10-41-25 | Length 11 mm | In distribution |
| 83-02-14-10 | 10×40 | In distribution |
| 10-10-41-28 | 14×35 | In distribution |
| 83-02-20-13 | 13×25 | In distribution |
| 10-10-41-21 | 7×35 | In distribution |
| 83-04-07-10 | 10x25mm Trial | In distribution |
| 83-02-42-11 | Length 11 mm | In distribution |
| 83-02-42-8 | Length 8 mm | In distribution |
| 10-10-41-4 | Length 10 mm | In distribution |
| 83-02-44-9 | Length 9 mm | In distribution |
| 83-04-07-36 | Height 16 mm | In distribution |
| 83-02-12-7 | 7×35 | In distribution |
| 83-02-14-11 | Length 11 mm | In distribution |
| 83-02-44-7 | Length 7 mm | In distribution |
| 83-04-07-29 | Height 9 mm | In distribution |
| 83-04-07-45 | Height 15 mm | In distribution |
| 83-02-16-7 | 7×25 | In distribution |
| 83-04-07-34 | Height 14 mm | In distribution |
| 10-10-41-24 | Length 10 mm | In distribution |
| 10-10-41-6 | Length 12 mm | In distribution |
| 83-04-07-44 | 14x40mm Trial | In distribution |
| 83-02-10-13 | Length 13 mm | In distribution |
| 83-02-10-16 | 16×30 | In distribution |
| 10-10-41-22 | Length 8 mm | In distribution |
| 83-02-12-9 | 9×35 | In distribution |
| 83-02-18-7 | 7×30 | In distribution |
| 10-10-41-2 | Length 8 mm | In distribution |
| 83-04-07-32 | 12x35mm Trial | In distribution |
| 10-10-41-8 | 14×25 | In distribution |
| 83-02-14-8 | Length 8 mm | In distribution |
| 83-04-07-30 | 10x35mm Trial | In distribution |
| 83-02-42-10 | Length 10 mm | In distribution |
| 83-02-12-12 | 12×35 | In distribution |
| 83-02-44-12 | 12×40 | In distribution |
| 10-10-41-1 | Length 7 mm | In distribution |
| 83-02-20-7 | 7×25 | In distribution |
| 83-02-16-13 | Length 13 mm | In distribution |
| 83-02-44-15 | Length 15 mm | In distribution |
| 83-04-08 | Implant Inserter | In distribution |
| 83-04-07-33 | Height 13 mm | In distribution |
| 83-02-20-16 | 16×25 | In distribution |
| 10-10-41-31 | Length 7 mm | In distribution |
| 83-04-07-20 | 10x30mm Trial | In distribution |
| 83-02-12-13 | 13×35 | In distribution |
| 10-10-41-33 | Length 9 mm | In distribution |
| 83-04-07-12 | Height 12 mm | In distribution |
| 83-02-44-14 | 14×40 | In distribution |
| 83-04-07-26 | 16x30mm Trial | In distribution |
| 83-04-07-39 | Height 9 mm | In distribution |
| 83-04-07-31 | Height 11 mm | In distribution |
| 83-04-07-21 | Height 11 mm | In distribution |
| 83-04-07-37 | Height 7 mm | In distribution |
| 83-02-16-15 | Length 15 mm | In distribution |
| 83-02-18-10 | Length 10 mm | In distribution |
| 83-02-42-16 | 16×35 | In distribution |
| 10-10-41-7 | Length 13 mm | In distribution |
| 83-02-10-15 | Length 15 mm | In distribution |
| 83-04-07-24 | 14x30mm Trial | In distribution |
| 10-10-41-34 | Length 10 mm | In distribution |
| 83-02-18-9 | Length 9 mm | In distribution |
| 83-04-07-9 | Height 9 mm | In distribution |
| 83-02-12-14 | Length 14 mm | In distribution |
| 83-02-20-10 | 10×25 | In distribution |
| 83-02-10-7 | Length 7 mm | In distribution |
| 10-10-41-32 | Length 8 mm | In distribution |
| 83-02-14-15 | Length 15 mm | In distribution |
| 83-02-42-12 | 12×35 | In distribution |
| 10-10-41-9 | 15×25 | In distribution |
| 83-04-07-22 | Height 12 mm | In distribution |
| 83-04-07-35 | Height 15 mm | In distribution |
| 83-02-18-8 | 8×30 | In distribution |
| 83-02-12-11 | 11×35 | In distribution |
| 83-04-07-14 | 14x25mm Trial | In distribution |
| 83-04-07-40 | Height 10 mm | In distribution |
| 10-10-41-18 | 14×30 | In distribution |
| 83-02-42-9 | 9×35 | In distribution |
| 10-10-41-36 | Length 12 mm | In distribution |
| 83-04-07-7 | Height 7 mm | In distribution |
| 10-10-41-16 | Length 12 mm | In distribution |
| 83-02-18-15 | Length 15 mm | In distribution |
| 83-04-07-42 | Height 12 mm | In distribution |
| 83-04-07-23 | 13x30mm Trial | In distribution |
| 83-04-07-28 | Height 8 mm | In distribution |
| 83-02-12-15 | 15×35 | In distribution |
| 83-02-42-7 | 7×35 | In distribution |
| 10-10-41-3 | 9×25 | In distribution |
| 10-10-41-12 | 8×30 | In distribution |
| 83-02-14-14 | 14×40 | In distribution |
| 83-02-20-14 | Length 14 mm | In distribution |
| 83-02-10-11 | 11×30 | In distribution |
| 83-04-07-18 | Height 8 mm | In distribution |
| 83-04-07-27 | Height 7 mm | In distribution |
| 83-02-16-9 | Length 9 mm | In distribution |
| 83-04-07-13 | 13x25mm Trial | In distribution |
| 83-02-12-8 | Length 8 mm | In distribution |
| 83-02-44-11 | Length 11 mm | In distribution |
| 10-10-41-17 | 13×30 | In distribution |
| 10-10-41-14 | Length 10 mm | In distribution |
| 83-02-14-16 | 16×40 | In distribution |
| 10-10-41-23 | Length 9 mm | In distribution |
| 83-02-10-8 | 8×30 | In distribution |
| 83-04-07-17 | Height 7 mm | In distribution |
| 10-10-41-40 | Length 16 mm | In distribution |
| 83-02-20-11 | Length 11 mm | In distribution |
| 10-10-41-10 | Length 16 mm | In distribution |
| 10-10-41-11 | 7×30 | In distribution |
| 10-10-41-38 | 14×40 | In distribution |
| 83-02-14-9 | Length 9 mm | In distribution |
| 83-02-10-9 | Length 9 mm | In distribution |
| 10-10-41-37 | 13×40 | In distribution |
| 83-02-12-16 | 16×35 | In distribution |
| 83-02-44-10 | Length 10 mm | In distribution |
| 10-10-41-35 | 11×40 | In distribution |
| 83-04-07-11 | Height 11 mm | In distribution |
| 83-04-07-19 | Height 9 mm | In distribution |
| 10-10-41-5 | Length 11 mm | In distribution |
| 83-02-14-13 | 13×40 | In distribution |
| 10-10-41-15 | 11×30 | In distribution |
| 83-02-20-15 | Length 15 mm | In distribution |
| 83-02-16-10 | Length 10 mm | In distribution |
| 83-04-07-25 | Height 15 mm | In distribution |
| 83-02-18-13 | 13×30 | In distribution |
| 83-02-18-14 | Length 14 mm | In distribution |
| 10-10-41-5 | Length 11 mm | Withdrawn |
| 10-10-41-6 | 12×25 | Withdrawn |
| 10-10-41-9 | 15×25 | Withdrawn |
| 10-10-41-3 | Length 9 mm | Withdrawn |
| 10-10-41-7 | 13×25 | Withdrawn |
| 10-10-41-2 | 8×25 | Withdrawn |
| 10-10-41-4 | 10×25 | Withdrawn |
| 10-10-41-1 | 7×25 | Withdrawn |
| 10-10-41-10 | Length 16 mm | Withdrawn |
| 10-10-41-8 | 14×25 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Peridot Intervertebral body fusion system | Gbs Commonwealth Co., Ltd. | 10,850 |
| Yellowstone | Summit Spine | 6,654 |
| CoRoent | Nuvasive, Inc. | 5,690 |
| Zavation | Zavation | 2,554 |
| Anyplus II Spinal Fixation System | GS Medical Co., Ltd. | 2,533 |
| Talos® IBF | Meditech Spine, LLC | 2,163 |
| Peridot-PT Intervertebral body fusion system | Gbs Commonwealth Co., Ltd. | 1,956 |
| TirboLOX-L Lumbar Ibfd | Captiva Spine, Inc. | 1,926 |
| Endoskeleton® TL | Titan Spine, LLC | 1,896 |
| Evos Lumbar Interbody System | Cutting Edge Spine | 1,871 |
| Epiphany | Pantheon Spinal LLC | 1,507 |
| LnK Lumbar Interbody Fusion Cage System | L&K Biomed Co., Ltd. | 1,506 |
Showing 12 of 1,958. All products under Intervertebral Fusion Device With Bone Graft, Lumbar
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K210155 | 2021-02-19 |
| K190055 | 2019-03-07 |
| K182322 | 2018-10-24 |
| K181792 | 2018-08-14 |
| K171660 | 2017-08-18 |
| K171724 | 2017-07-24 |
| K163409 | 2017-03-08 |
| K162879 | 2017-01-30 |
| K160074 | 2016-10-18 |
| K160906 | 2016-07-14 |
| K153082 | 2016-02-04 |
| K151020 | 2015-07-22 |
| K133371 | 2014-01-09 |
| K132053 | 2013-09-16 |
| K131216 | 2013-05-30 |
| K130396 | 2013-03-25 |
| K123652 | 2013-03-22 |
| K121129 | 2012-06-13 |
| K120293 | 2012-02-29 |
| K113030 | 2012-01-26 |
| K111880 | 2011-09-26 |
| K110933 | 2011-06-13 |
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
| PMA number | Decision | Trade name | Approved to |
|---|---|---|---|
| P000028 | 2004-06-18 | AFFINITY ANTERIOR CERVICAL CAGE SYSTEM | Medtronic Sofamor Danek USA, Inc. |
| P970015 | 2003-09-10 | LT-CAGE PEEK LUMBAR TAPERED FUSION DEVICE | Sofamor Danek |
| P980048 | 2001-04-20 | BAK/CERVICAL (BAK/C) INTERBODY FUSION SYSTEM | Sulzer Spine-Tech |
| P950019 | 1999-03-19 | RAY THREADED FUSION CAGE (TFC) DEVICE WITH INSTRUMENTATION | Stryker Spine |
| P950002 | 1997-06-30 | BAK INTERBODY FUSION SYSTEM | Zimmer Spine, Inc. |
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.