E3D®-C Interbody System
The integrated E3D-C cervical interbody is a titanium alloy fusion implant placed through an anterior approach. It accepts two bone screws or two anchors into adjacent vertebral bodies. An…
The integrated E3D-C cervical interbody is a titanium alloy fusion implant placed through an anterior approach. It accepts two bone screws or two anchors into adjacent vertebral bodies. An integral cam mechanism locks the screw connections. The range includes implants with a thin hydroxyapatite nanosurface treatment.
The system is intended for skeletally mature patients at one or more cervical levels from C2 to T1 after at least six weeks of nonoperative treatment. Indications include degenerative disc disease, instability, trauma, deformity, cervical spondylotic myelopathy, stenosis and failed fusion.
Listed Item
HAnano Integrated Cervical 16’14mm 12Deg 11mm
Fixation and Graft Requirements
Integrated interbodies used with two screws can function as stand-alone fusion devices. Use with anchors, or without screws, requires supplemental fixation. The implants are filled with autograft or cancellous, cortical or corticocancellous allogeneic bone graft. The separate static interbody configuration also requires supplemental fixation.
5manufacturers in China registered for this device type
218catalogue numbers in this listing
3510(k) clearances naming this product code
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 | Evolution Spine, LLC, United States |
|---|---|
| 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, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K241846 |
| Record published | 2024-10-04 |
| Record revised | 2025-07-14 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Sizes | Depth 12 to 16 mm; width 14 to 18 mm; height 5 to 12 mm; angle 7 to 15 °; length 10 to 26 mm; outer diameter 3.5 to 4 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 130G-S1212 | Depth 12 mm | In distribution |
| 130G-3XL1508 | In distribution | |
| 131G-M1210 | Height 10 mm | In distribution |
| 130G-S0706 | Height 6 mm | In distribution |
| 131H-M0706 | Angle 7 ° | In distribution |
| 131G-3XL1508 | In distribution | |
| 130H-M0709 | Width 16 mm | In distribution |
| 130G-S1512 | Depth 12 mm | In distribution |
| 131H-L1506 | Angle 15 ° | In distribution |
| 130G-S0709 | Depth 12 mm | In distribution |
| 130H-4020-2 | Outer Diameter 4 mm | In distribution |
| 130H-3516 | Length 16 mm | In distribution |
| 130G-S1511 | Angle 15 ° | In distribution |
| 131G-M1512 | Height 12 mm | In distribution |
| 131G-XL0711 | In distribution | |
| 130G-XL1207 | In distribution | |
| 131G-S1210 | Width 14 mm | In distribution |
| 130H-4010 | Length 10 mm | In distribution |
| 130H-S1209 | Depth 12 mm | In distribution |
| 130G-2XL0709 | In distribution | |
| 130G-XL0712 | In distribution | |
| 131G-2XL1206 | In distribution | |
| 130G-M1510 | Width 16 mm | In distribution |
| 132H-16 | Length 16 mm | In distribution |
| 132-14 | Length 14 mm | In distribution |
| 130G-M1208 | Angle 12 ° | In distribution |
| 131G-L0711 | Angle 7 ° | In distribution |
| 131H-L1206 | Angle 12 ° | In distribution |
| 132-18 | Length 18 mm | In distribution |
| 131G-M1509 | Angle 15 ° | In distribution |
| 130G-XL1210 | In distribution | |
| 130H-4020 | Outer Diameter 4 mm | In distribution |
| 131H-M1506 | Width 16 mm | In distribution |
| 130H-M1508 | Angle 15 ° | In distribution |
| 131G-XL0708 | In distribution | |
| 131G-XL1509 | In distribution | |
| 131H-S1508 | Angle 15 ° | In distribution |
| 130H-4022 | Length 22 mm | In distribution |
| 131G-S0711 | Width 14 mm | In distribution |
| 130H-L0709 | Angle 7 ° | In distribution |
| 130G-S0708 | Width 14 mm | In distribution |
| 131G-2XL1212 | In distribution | |
| 130G-XL1209 | In distribution | |
| 130G-2XL0711 | In distribution | |
| 130G-L1508 | Depth 16 mm | In distribution |
| 131H-S1506 | Width 14 mm | In distribution |
| 130H-4014-2 | Length 14 mm | In distribution |
| 130G-XL0706 | In distribution | |
| 131H-L1209 | Angle 12 ° | In distribution |
| 131G-XL1206 | In distribution | |
| 131G-S1208 | Angle 12 ° | In distribution |
| 130H-3522 | Outer Diameter 3.5 mm | In distribution |
| 130H-S1507 | Width 14 mm | In distribution |
| 131H-L1211 | Width 18 mm | In distribution |
| 130H-M0705 | Angle 7 ° | In distribution |
| 130-4024 | Length 24 mm | In distribution |
| 131G-M1508 | Angle 15 ° | In distribution |
| 130H-M1211 | Height 11 mm | In distribution |
| 130H-M0706 | Width 16 mm | In distribution |
| 131H-L0707 | Depth 16 mm | In distribution |
| 131G-M1212 | Depth 14 mm | In distribution |
| 130H-S0709 | Width 14 mm | In distribution |
| 130G-S1210 | Height 10 mm | In distribution |
| 130H-3514 | Length 14 mm | In distribution |
| 130H-4012-2 | Length 12 mm | In distribution |
| 130G-M0707 | Width 16 mm | In distribution |
| 130G-3XL1207 | In distribution | |
| 131G-L0709 | Height 9 mm | In distribution |
| 130G-3XL1208 | In distribution | |
| 131G-S1211 | Depth 12 mm | In distribution |
| 131G-2XL1511 | In distribution | |
| 130H-M0712 | Height 12 mm | In distribution |
| 131H-S0708 | Angle 7 ° | In distribution |
| 130-4016 | Length 16 mm | In distribution |
| 130H-4016 | Length 16 mm | In distribution |
| 131G-M0711 | Angle 7 ° | In distribution |
| 132H-12-2 | Length 12 mm | In distribution |
| 130H-S0712 | Angle 7 ° | In distribution |
| 130H-S0711 | Depth 12 mm | In distribution |
| 131G-XL0712 | In distribution | |
| 130G-L1206 | Width 18 mm | In distribution |
| 130H-M1206 | Height 6 mm | In distribution |
| 130G-3XL1209 | In distribution | |
| 130G-S0711 | Angle 7 ° | In distribution |
| 130H-L1207 | Height 7 mm | In distribution |
| 130G-2XL0706 | In distribution | |
| 130G-XL0705 | In distribution | |
| 130H-3516-2 | Outer Diameter 3.5 mm | In distribution |
| 131H-M0710 | Height 10 mm | In distribution |
| 132H-10-2 | Length 10 mm | In distribution |
| 130-3522 | Length 22 mm | In distribution |
| 131G-S1510 | Width 14 mm | In distribution |
| 131G-3XL0709 | In distribution | |
| 131H-S0705 | Width 14 mm | In distribution |
| 131G-M0705 | Height 5 mm | In distribution |
| 131H-M1212 | Height 12 mm | In distribution |
| 131G-M0709 | Height 9 mm | In distribution |
| 130H-3520-2 | Outer Diameter 3.5 mm | In distribution |
| 131G-L0706 | Angle 7 ° | In distribution |
| 130G-M1212 | Width 16 mm | In distribution |
| 131H-L1212 | Width 18 mm | In distribution |
| 130G-XL0711 | In distribution | |
| 131G-XL1512 | In distribution | |
| 130H-4022-2 | Outer Diameter 4 mm | In distribution |
| 130G-2XL1508 | In distribution | |
| 130G-S1209 | Depth 12 mm | In distribution |
| 130H-3510 | Length 10 mm | In distribution |
| 130G-3XL0711 | In distribution | |
| 130H-L0710 | Height 10 mm | In distribution |
| 130G-L0705 | Width 18 mm | In distribution |
| 131H-M1210 | Height 10 mm | In distribution |
| 131G-S1209 | Angle 12 ° | In distribution |
| 131G-2XL1209 | In distribution | |
| 131H-M1511 | Height 11 mm | In distribution |
| 131G-3XL1512 | In distribution | |
| 130G-2XL0708 | In distribution | |
| 130H-M0711 | Depth 14 mm | In distribution |
| 131H-L0710 | Depth 16 mm | In distribution |
| 130G-2XL0705 | In distribution | |
| 131G-M1211 | Width 16 mm | In distribution |
| 130G-3XL1512 | In distribution | |
| 130G-S1508 | Width 14 mm | In distribution |
| 130G-S1507 | Height 7 mm | In distribution |
| 130G-M0709 | Angle 7 ° | In distribution |
| 131G-L0707 | Height 7 mm | In distribution |
| 130G-2XL1209 | In distribution | |
| 131H-S1208 | Angle 12 ° | In distribution |
| 131G-2XL0709 | In distribution | |
| 131H-S1206 | Depth 12 mm | In distribution |
| 130G-M1210 | Depth 14 mm | In distribution |
| 130G-M0712 | Depth 14 mm | In distribution |
| 130G-L0707 | Width 18 mm | In distribution |
| 131G-3XL1511 | In distribution | |
| 130G-3XL1509 | In distribution | |
| 131G-S0705 | Height 5 mm | In distribution |
| 130-4020 | Length 20 mm | In distribution |
| 130H-L0707 | Depth 16 mm | In distribution |
| 131G-M0707 | Height 7 mm | In distribution |
| 131H-M1208 | Height 8 mm | In distribution |
| 131G-3XL0710 | In distribution | |
| 130G-2XL1506 | In distribution | |
| 130H-3510-2 | Outer Diameter 3.5 mm | In distribution |
| 130G-L0711 | Depth 16 mm | In distribution |
| 130H-3512-2 | Length 12 mm | In distribution |
| 132-12 | Length 12 mm | In distribution |
| 130H-L1209 | Angle 12 ° | In distribution |
| 131G-2XL1210 | In distribution | |
| 130G-S1208 | Height 8 mm | In distribution |
| 130G-S1506 | Depth 12 mm | In distribution |
| 132-10 | Length 10 mm | In distribution |
| 130G-2XL0712 | In distribution | |
| 130G-L0708 | Depth 16 mm | In distribution |
| 131G-L0712 | Angle 7 ° | In distribution |
| 131H-M1209 | Height 9 mm | In distribution |
| 130H-3526-2 | Outer Diameter 3.5 mm | In distribution |
| 130H-3524 | Outer Diameter 3.5 mm | In distribution |
| 130G-XL1212 | In distribution | |
| 130H-M1209 | Depth 14 mm | In distribution |
| 132H-14 | Length 14 mm | In distribution |
| 130H-S1512 | Width 14 mm | In distribution |
| 130H-L1510 | Width 18 mm | In distribution |
| 132H-10 | Length 10 mm | In distribution |
| 131G-XL1506 | In distribution | |
| 130H-S1508 | Width 14 mm | In distribution |
| 131G-XL0706 | In distribution | |
| 130H-L1208 | Height 8 mm | In distribution |
| 130G-3XL0707 | In distribution | |
| 131H-L1507 | Height 7 mm | In distribution |
| 130H-L0711 | Depth 16 mm | In distribution |
| 130-3516 | Outer Diameter 3.5 mm | In distribution |
| 130G-2XL1207 | In distribution | |
| 130H-L1212 | Depth 16 mm | In distribution |
| 130G-S1207 | Height 7 mm | In distribution |
| 130H-S1208 | Depth 12 mm | In distribution |
| 131H-M0705 | Width 16 mm | In distribution |
| 131G-S1506 | Height 6 mm | In distribution |
| 131G-3XL1506 | In distribution | |
| 130G-2XL0707 | In distribution | |
| 131G-S1507 | Width 14 mm | In distribution |
| 130G-L1506 | Height 6 mm | In distribution |
| 131G-3XL1211 | In distribution | |
| 130G-S0707 | Width 14 mm | In distribution |
| 130H-4018-2 | Length 18 mm | In distribution |
| 130H-M1207 | Width 16 mm | In distribution |
| 131G-M1510 | Width 16 mm | In distribution |
| 130G-3XL0708 | In distribution | |
| 130H-M1509 | Height 9 mm | In distribution |
| 130G-2XL1211 | In distribution | |
| 130G-L1510 | Width 18 mm | In distribution |
| 130H-S1206 | Width 14 mm | In distribution |
| 130G-M0711 | Width 16 mm | In distribution |
| 131H-S1512 | Depth 12 mm | In distribution |
| 130H-4026-2 | Outer Diameter 4 mm | In distribution |
| 130H-S1511 | Angle 15 ° | In distribution |
| 130G-XL1206 | In distribution | |
| 130H-M1210 | Depth 14 mm | In distribution |
| 130G-M0710 | Width 16 mm | In distribution |
| 131G-L0705 | Width 18 mm | In distribution |
| 131G-L1511 | Depth 16 mm | In distribution |
| 131G-XL1207 | In distribution | |
| 131G-S1511 | Height 11 mm | In distribution |
| 130H-4024 | Length 24 mm | In distribution |
| 130H-L0705 | Width 18 mm | In distribution |
| 130H-3518 | Outer Diameter 3.5 mm | In distribution |
| 131H-L1210 | Depth 16 mm | In distribution |
| 130H-3514-2 | Length 14 mm | In distribution |
| 130G-L1512 | Depth 16 mm | In distribution |
| 130H-L0706 | Angle 7 ° | In distribution |
| 131G-3XL1510 | In distribution | |
| 132H-12 | Length 12 mm | In distribution |
| 130H-L1511 | Angle 15 ° | In distribution |
| 130G-M0708 | Height 8 mm | In distribution |
| 131G-S1508 | Depth 12 mm | In distribution |
| 131G-3XL1208 | In distribution | |
| 130-3518 | Length 18 mm | In distribution |
| 131G-S0708 | Angle 7 ° | In distribution |
| 131G-XL1510 | In distribution | |
| 131H-S1511 | Angle 15 ° | In distribution |
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 |
|---|---|
| K262094 | 2026-07-22 |
| K260038 | 2026-02-04 |
| K241846 | 2024-08-12 |
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.