BluEX Cervical Expandable Cage System
BluEX Cervical Expandable Cage is a titanium alloy interbody fusion implant inserted in a collapsed state after disc removal. Dedicated instruments then expand its height within the disc…
BluEX Cervical Expandable Cage is a titanium alloy interbody fusion implant inserted in a collapsed state after disc removal. Dedicated instruments then expand its height within the disc space. Serrations on the upper and lower surfaces engage the adjacent vertebral endplates.
The system is intended for anterior cervical fusion in skeletally mature patients with disc degeneration or instability causing radiculopathy, myelopathy or pain at multiple contiguous levels from C2 to T1. Patients should have had at least six weeks of nonoperative treatment. Supplemental fixation is required.
Listed Item
BluEX-C (12 X 14 X 12 mm, 0 °)
Graft and Supply
A central chamber holds autogenous graft or cancellous or corticocancellous allogeneic bone graft. The range offers different widths, lengths, heights and lordotic angles for patient anatomy. Implants are supplied sterile for single use, with the titanium alloy conforming to ASTM F136.
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 | L&K Biomed Co., Ltd., South Korea |
|---|---|
| FDA product code | ODP |
| Device type | Intervertebral Fusion Device With Bone Graft, Cervical |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K260840 |
| Record published | 2026-06-03 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1214-1200S | In distribution | |
| 1417-0500S | In distribution | |
| 1214-1300S | In distribution | |
| 1417-0807S | In distribution | |
| 1417-1000S | In distribution | |
| 1417-1107S | In distribution | |
| 1417-1307S | In distribution | |
| 1214-0900S | In distribution | |
| 1214-0600S | In distribution | |
| 1214-0700S | In distribution | |
| 1214-1007S | In distribution | |
| 1214-0707S | In distribution | |
| 1417-0507S | In distribution | |
| 1417-0707S | In distribution | |
| 1417-0907S | In distribution | |
| 1417-1200S | In distribution | |
| 1417-1007S | In distribution | |
| 1214-1100S | In distribution | |
| 1417-1207S | In distribution | |
| 1214-0500S | In distribution | |
| 1214-0807S | In distribution | |
| 1417-0607S | In distribution | |
| 1214-0407S | In distribution | |
| 1417-0600S | In distribution | |
| 1417-0900S | In distribution | |
| 1214-0907S | In distribution | |
| 1417-1300S | In distribution | |
| 1417-0700S | In distribution | |
| 1214-0607S | In distribution | |
| 1214-0507S | In distribution | |
| 1214-0400S | In distribution | |
| 1417-1100S | In distribution | |
| 1214-1207S | In distribution | |
| 1214-0800S | In distribution | |
| 1417-0407S | In distribution | |
| 1417-0800S | In distribution | |
| 1214-1000S | In distribution | |
| 1214-1107S | In distribution | |
| 1214-1307S | In distribution | |
| 1417-0400S | 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 |
|---|---|
| K262489 | 2026-08-18 |
| K260840 | 2026-05-16 |
| K151677 | 2015-07-15 |
| K143360 | 2015-04-03 |
| K120840 | 2012-05-24 |
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.