Anterior Cervical Ibfd
The Keos Anterior Cervical Interbody Fusion Device is a spacer placed between adjacent cervical vertebral bodies to support fusion. The listed PEEK configurations have a hollow chamber for…
The Keos Anterior Cervical Interbody Fusion Device is a spacer placed between adjacent cervical vertebral bodies to support fusion. The listed PEEK configurations have a hollow chamber for autogenous bone graft, teeth on their upper and lower surfaces, and tantalum markers for imaging visibility.
The spacer is inserted from the front at one level between C2 and T1 in skeletally mature patients with degenerative disc disease and accompanying radicular symptoms. It requires supplemental fixation cleared for the cervical spine, following at least six weeks of nonoperative treatment.
Implant Configuration
The spacers are offered in different footprints, heights and lordotic angles to accommodate anatomy. The implants are for single use and are supplied nonsterile for sterilization by the end user before implantation.
7manufacturers in China registered for this device type
112catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Shanghai (2), Shandong (2), Zhejiang (2). 3 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 |
| Zhisu Health Tech Jiaxing Co., Ltd. | Tongxiang | Zhejiang | Contract manufacturer | 4 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Zhejiang Decans Medical Devices Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 10 |
| Shanghai Sanyou Medical Co., Ltd. | Shanghai | Shanghai | Manufacturer | 6 |
Record
| Listed by | Keos, United States |
|---|---|
| FDA product code | ODP |
| Device type | Intervertebral Fusion Device With Bone Graft, Cervical |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K212450 |
| Record published | 2023-12-21 |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 12D x 14W x 06H x 7L, PEEK-HA | In distribution | |
| 16D x 18W x 10H x 4L, PEEK | In distribution | |
| 12D x 14W x 06H x 4L, PEEK | In distribution | |
| 12D x 14W x 10H x 7L, PEEK-HA | In distribution | |
| 12D x 14W x 12H x 0L, PEEK | In distribution | |
| 11D x 13W x 05H x 4L, PEEK | In distribution | |
| 14D x 16W x 12H x 0L, PEEK | In distribution | |
| 11D x 13W x 05H x 0L, PEEK | In distribution | |
| 11D x 13W x 11H x 0L, PEEK | In distribution | |
| 16D x 18W x 11H x 4L, PEEK | In distribution | |
| 11D x 13W x 06H x 4L, PEEK | In distribution | |
| 14D x 16W x 11H x 4L, PEEK | In distribution | |
| 14D x 16W x 07H x 7L, PEEK-HA | In distribution | |
| 11D x 13W x 11H x 4L, PEEK | In distribution | |
| 16D x 18W x 11H x 7L, PEEK | In distribution | |
| 12D x 14W x 07H x 0L, PEEK | In distribution | |
| 14D x 16W x 08H x 7L, PEEK | In distribution | |
| 12D x 14W x 10H x 7L, PEEK | In distribution | |
| 14D x 16W x 05H x 7L, PEEK | In distribution | |
| 14D x 16W x 10H x 4L, PEEK | In distribution | |
| 12D x 14W x 11H x 0L, PEEK | In distribution | |
| 14D x 16W x 09H x 0L, PEEK | In distribution | |
| 16D x 18W x 05H x 4L, PEEK | In distribution | |
| 11D x 13W x 10H x 7L, PEEK | In distribution | |
| 16D x 18W x 12H x 7L, PEEK | In distribution | |
| 16D x 18W x 07H x 0L, PEEK | In distribution | |
| 14D x 16W x 11H x 7L, PEEK | In distribution | |
| 14D x 16W x 06H x 4L, PEEK | In distribution | |
| 14D x 16W x 11H x 7L, PEEK-HA | In distribution | |
| 16D x 18W x 10H x 7L, PEEK | In distribution | |
| 14D x 16W x 11H x 0L, PEEK | In distribution | |
| 12D x 14W x 05H x 7L, PEEK-HA | In distribution | |
| 12D x 14W x 09H x 4L, PEEK | In distribution | |
| 14D x 16W x 05H x 7L, PEEK-HA | In distribution | |
| 11D x 13W x 07H x 7L, PEEK | In distribution | |
| 14D x 16W x 10H x 7L, PEEK | In distribution | |
| 14D x 16W x 12H x 4L, PEEK | In distribution | |
| 12D x 14W x 07H x 7L, PEEK-HA | In distribution | |
| 14D x 16W x 08H x 4L, PEEK | In distribution | |
| 12D x 14W x 08H x 7L, PEEK | In distribution | |
| 12D x 14W x 05H x 0L, PEEK | In distribution | |
| 12D x 14W x 10H x 4L, PEEK | In distribution | |
| 16D x 18W x 09H x 0L, PEEK | In distribution | |
| 14D x 16W x 05H x 4L, PEEK | In distribution | |
| 12D x 14W x 06H x 7L, PEEK | In distribution | |
| 12D x 14W x 08H x 0L, PEEK | In distribution | |
| 16D x 18W x 06H x 4L, PEEK | In distribution | |
| 11D x 13W x 05H x 7L, PEEK | In distribution | |
| 12D x 14W x 09H x 7L, PEEK-HA | In distribution | |
| 16D x 18W x 06H x 7L, PEEK | In distribution | |
| 16D x 18W x 08H x 0L, PEEK | In distribution | |
| 14D x 16W x 10H x 0L, PEEK | In distribution | |
| 16D x 18W x 07H x 7L, PEEK | In distribution | |
| 14D x 16W x 08H x 0L, PEEK | In distribution | |
| 11D x 13W x 09H x 0L, PEEK | In distribution | |
| 12D x 14W x 12H x 4L, PEEK | In distribution | |
| 11D x 13W x 10H x 0L, PEEK | In distribution | |
| 16D x 18W x 07H x 4L, PEEK | In distribution | |
| 14D x 16W x 09H x 7L, PEEK-HA | In distribution | |
| 14D x 16W x 12H x 7L, PEEK | In distribution | |
| 14D x 16W x 12H x 7L, PEEK-HA | In distribution | |
| 12D x 14W x 08H x 7L, PEEK-HA | In distribution | |
| 11D x 13W x 09H x 4L, PEEK | In distribution | |
| 12D x 14W x 12H x 7L, PEEK | In distribution | |
| 11D x 13W x 11H x 7L, PEEK | In distribution | |
| 14D x 16W x 09H x 7L, PEEK | In distribution | |
| 16D x 18W x 11H x 0L, PEEK | In distribution | |
| 16D x 18W x 09H x 4L, PEEK | In distribution | |
| 16D x 18W x 12H x 4L, PEEK | In distribution | |
| 14D x 16W x 07H x 0L, PEEK | In distribution | |
| 12D x 14W x 07H x 4L, PEEK | In distribution | |
| 11D x 13W x 08H x 0L, PEEK | In distribution | |
| 12D x 14W x 05H x 4L, PEEK | In distribution | |
| 14D x 16W x 06H x 7L, PEEK | In distribution | |
| 16D x 18W x 08H x 4L, PEEK | In distribution | |
| 11D x 13W x 12H x 0L, PEEK | In distribution | |
| 11D x 13W x 06H x 7L, PEEK | In distribution | |
| 16D x 18W x 10H x 0L, PEEK | In distribution | |
| 12D x 14W x 11H x 4L, PEEK | In distribution | |
| 12D x 14W x 07H x 7L, PEEK | In distribution | |
| 16D x 18W x 05H x 0L, PEEK | In distribution | |
| 14D x 16W x 08H x 7L, PEEK-HA | In distribution | |
| 12D x 14W x 09H x 0L, PEEK | In distribution | |
| 14D x 16W x 06H x 7L, PEEK-HA | In distribution | |
| 11D x 13W x 09H x 7L, PEEK | In distribution | |
| 16D x 18W x 06H x 0L, PEEK | In distribution | |
| 14D x 16W x 09H x 4L, PEEK | In distribution | |
| 11D x 13W x 08H x 4L, PEEK | In distribution | |
| 11D x 13W x 12H x 7L, PEEK | In distribution | |
| 14D x 16W x 06H x 0L, PEEK | In distribution | |
| 16D x 18W x 09H x 7L, PEEK | In distribution | |
| 14D x 16W x 10H x 7L, PEEK-HA | In distribution | |
| 12D x 14W x 09H x 7L, PEEK | In distribution | |
| 14D x 16W x 07H x 4L, PEEK | In distribution | |
| 11D x 13W x 08H x 7L, PEEK | In distribution | |
| 12D x 14W x 10H x 0L, PEEK | In distribution | |
| 12D x 14W x 11H x 7L, PEEK-HA | In distribution | |
| 11D x 13W x 12H x 4L, PEEK | In distribution | |
| 16D x 18W x 05H x 7L, PEEK | In distribution | |
| 14D x 16W x 07H x 7L, PEEK | In distribution | |
| 12D x 14W x 06H x 0L, PEEK | In distribution | |
| 11D x 13W x 07H x 4L, PEEK | In distribution | |
| 16D x 18W x 08H x 7L, PEEK | In distribution | |
| 11D x 13W x 07H x 0L, PEEK | In distribution | |
| 12D x 14W x 08H x 4L, PEEK | In distribution | |
| 12D x 14W x 05H x 7L, PEEK | In distribution | |
| 11D x 13W x 06H x 0L, PEEK | In distribution | |
| 12D x 14W x 12H x 7L, PEEK-HA | In distribution | |
| 11D x 13W x 10H x 4L, PEEK | In distribution | |
| 12D x 14W x 11H x 7L, PEEK | In distribution | |
| 14D x 16W x 05H x 0L, PEEK | In distribution | |
| 16D x 18W x 12H x 0L, PEEK | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Latitude-C AM™ Cervical Interbody Fusion System | Degen Medical | 1,529 |
| IdentiTi | Alphatec Spine, Inc. | 1,390 |
| Zavation | Zavation | 1,357 |
| IVA Cage Ti | Diomedical Co., Ltd. | 1,202 |
| Latitude-C Cervical Interbody Spacer System | Degen Medical | 1,185 |
| Peridot Anterior Cervical Intervertebral Body Fusion System | Gbs Commonwealth Co., Ltd. | 1,056 |
| Aleutian® Interbody Systems | VB Spine LLC | 1,017 |
| Valeo Spacer System | Sintx Technologies Inc. | 918 |
| Cascadia™ Interbody System | VB Spine LLC | 823 |
| CoRoent | Nuvasive, Inc. | 815 |
| Tyber Medical | Tyber Medical | 740 |
| Matisse Anterior Cervical Interbody Fusion Cage System | CTL Medical Corporation | 577 |
Showing 12 of 938. All products under Intervertebral Fusion Device With Bone Graft, Cervical
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K212450 | 2022-06-06 |
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.