C-Curve
C-Curve is a titanium alloy cervical cage whose height and lordotic angle can be adjusted through a preassembled expansion screw. It is inserted between adjacent vertebrae through an…
C-Curve is a titanium alloy cervical cage whose height and lordotic angle can be adjusted through a preassembled expansion screw. It is inserted between adjacent vertebrae through an anterior approach after disc removal. Two separately supplied C-Curve screws stabilize the cage.
Use is intended for skeletally mature patients with degenerative disc disease at one level from C2 to T1 after six weeks of nonoperative treatment. The cage can function as a stand-alone system with both integrated screws; without them, supplemental cervical fixation is required.
Listed Item
C-Curve° lordosable Ti 17x12x6mm
Graft and Implant Range
Graft options include autograft, cancellous or corticocancellous allograft, or demineralized allograft with bone marrow aspirate. Cages are available in different footprints and heights. Cage and screw implants are Ti-6Al-4V ELI titanium alloy and are not reusable.
Who Else Makes It
Concentrated in Zhejiang (2), Guangdong (1), Jiangsu (1). 3 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 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Zhisu Health Tech Jiaxing Co., Ltd. | Tongxiang | Zhejiang | Contract manufacturer | 4 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Zhejiang Decans Medical Devices Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 10 |
Record
| Listed by | Medicrea International, France |
|---|---|
| FDA product code | OVE |
| Device type | Intervertebral Fusion Device With Integrated Fixation, Cervical |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K210470 |
| Record published | 2021-10-07 |
| Record revised | 2024-09-11 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Distribution end date | 2023-07-03 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| B20502163 | Withdrawn | |
| B20520017 | Withdrawn | |
| B20502283 | Withdrawn | |
| B20502273 | Withdrawn | |
| B20502173 | Withdrawn | |
| B20502253 | Withdrawn | |
| B20502153 | Withdrawn | |
| B20520013 | Withdrawn | |
| B20502183 | Withdrawn | |
| B20520015 | Withdrawn | |
| B20502263 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| IdentiTi | Alphatec Spine, Inc. | 630 |
| Dolomite | Astura Medical | 607 |
| CoRoent | Nuvasive, Inc. | 580 |
| Aeon-C | Diomedical Co., Ltd. | 508 |
| Tomcat™ Cervical Spinal System | Choice Spine, LP | 468 |
| Shoreline ACS | Seaspine Orthopedics Corporation | 428 |
| Zavation | Zavation | 423 |
| Alta™ Stand-Alone Interbody Fusion System | Biomet Spine | 404 |
| Unison™-C Anterior Cervical Fixation System | Pioneer Surgical Technology, Inc. | 334 |
| Chesapeake® Stabilization System | VB Spine LLC | 272 |
| UniSpace® Stand-Alone C Cage | CG MedTech Co., Ltd. | 260 |
| Solitaire-C Cervical Spacer | Biomet Spine | 256 |
Showing 12 of 391. All products under Intervertebral Fusion Device With Integrated Fixation, Cervical
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K210470 | 2021-09-03 |
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.