EVOL®ha-C Cervical Interbody System
EVOLha-C is a cervical interbody fusion system with spacers made from PEEK-OPTIMA LT120 HA. The implants have a central window for bone graft and teeth on the upper and lower surfaces to…
EVOLha-C is a cervical interbody fusion system with spacers made from PEEK-OPTIMA LT120 HA. The implants have a central window for bone graft and teeth on the upper and lower surfaces to resist migration between vertebral bodies.
Embedded tantalum beads make the spacer visible under fluoroscopy. Footprint, height and lordotic angle vary across the implant range to accommodate cervical anatomy.
Listed Item
EVOL®ha-C Cervical TRIAL 14WX12D 7° 9H-10H
Fusion and Instrument Roles
The spacers are used with autogenous and/or allogeneic cancellous or corticocancellous bone graft and supplemental fixation. The family also lists trial components used during the procedure; those trials are distinct from the implanted PEEK spacers. The fusion indication covers up to two adjacent levels from C2 to T1.
7manufacturers in China registered for this device type
111catalogue numbers in this listing
2510(k) clearances naming this product code
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 | Cutting Edge Spine, 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, Repacker / relabeller, Manufacturer |
| 510(k) | K180674 |
| Record published | 2018-08-15 |
| Record revised | 2024-09-11 (version 5) |
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, serial number |
| Storage | Special storage condition: Store at room temperature |
| Sizes | Length 12 to 600 mm; length 8 in |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 6011-09-7 | Length 18 mm | In distribution |
| 6006-05-7 | Length 12 mm | In distribution |
| 6010-10-7 | Length 16 mm | In distribution |
| CES-375 | Length 400 mm | In distribution |
| 6004-09-4 | Length 16 mm | In distribution |
| 6000-07-4 | Length 12 mm | In distribution |
| 6009-06-7 | Length 16 mm | In distribution |
| 6004-05-4 | Length 16 mm | In distribution |
| 6001-06-4 | Length 14 mm | In distribution |
| 6010-06-7 | Length 16 mm | In distribution |
| CES-357 | Length 400 mm | In distribution |
| 6009-05-7 | Length 16 mm | In distribution |
| 6007-06-7 | Length 14 mm | In distribution |
| CES-367 | Length 400 mm | In distribution |
| 6007-08-7 | Length 14 mm | In distribution |
| 6008-05-7 | Length 14 mm | In distribution |
| 6002-05-4 | Length 14 mm | In distribution |
| 6005-09-4 | Length 18 mm | In distribution |
| 6007-05-7 | Length 14 mm | In distribution |
| 6007-09-7 | Length 14 mm | In distribution |
| CES-379 | Length 400 mm | In distribution |
| CES-386 | Length 400 mm | In distribution |
| 6001-10-4 | Length 14 mm | In distribution |
| CES-360 | Length 400 mm | In distribution |
| 6002-06-4 | Length 14 mm | In distribution |
| 6011-07-7 | Length 18 mm | In distribution |
| CES-370 | Length 400 mm | In distribution |
| CES-387 | Length 400 mm | In distribution |
| CES-380 | Length 400 mm | In distribution |
| CES-368 | Length 400 mm | In distribution |
| 6003-07-4 | Length 16 mm | In distribution |
| CES-373 | Length 400 mm | In distribution |
| 6005-08-4 | Length 18 mm | In distribution |
| 6007-07-7 | Length 14 mm | In distribution |
| 6002-09-4 | Length 14 mm | In distribution |
| 6002-07-4 | Length 14 mm | In distribution |
| 6003-08-4 | Length 16 mm | In distribution |
| 6009-08-7 | Length 16 mm | In distribution |
| 6004-10-4 | Length 16 mm | In distribution |
| 6006-08-7 | Length 12 mm | In distribution |
| CES-472 | Length 50 mm | In distribution |
| CES-355 | Length 8 in | In distribution |
| 6003-06-4 | Length 16 mm | In distribution |
| 6001-07-4 | Length 14 mm | In distribution |
| 6007-10-7 | Length 14 mm | In distribution |
| 6002-10-4 | Length 14 mm | In distribution |
| 6000-05-4 | Length 12 mm | In distribution |
| 6006-07-7 | Length 12 mm | In distribution |
| 6006-06-7 | Length 12 mm | In distribution |
| CES-363 | Length 400 mm | In distribution |
| CES-354 | Length 8 in | In distribution |
| 6009-07-7 | Length 16 mm | In distribution |
| CES-393 | Length 400 mm | In distribution |
| CES-377 | Length 400 mm | In distribution |
| CES-369 | Length 400 mm | In distribution |
| 6010-08-7 | Length 16 mm | In distribution |
| CES-356 | Length 8 in | In distribution |
| CES-365 | Length 400 mm | In distribution |
| 6003-09-4 | Length 16 mm | In distribution |
| 6003-04-4 | Length 16 mm | In distribution |
| CES-391 | Length 400 mm | In distribution |
| 6002-08-4 | Length 14 mm | In distribution |
| 6008-10-7 | Length 14 mm | In distribution |
| 6000-06-4 | Length 12 mm | In distribution |
| 6000-10-4 | Length 12 mm | In distribution |
| CES-366 | Length 400 mm | In distribution |
| CES-390 | Length 400 mm | In distribution |
| 6001-09-4 | Length 14 mm | In distribution |
| 6008-08-7 | Length 14 mm | In distribution |
| CES-382 | Length 400 mm | In distribution |
| CES-358 | Length 400 mm | In distribution |
| 6008-09-7 | Length 14 mm | In distribution |
| 6004-06-4 | Length 16 mm | In distribution |
| CES-394 | Length 600 mm | In distribution |
| CES-381 | Length 400 mm | In distribution |
| CES-361 | Length 400 mm | In distribution |
| 6011-10-7 | Length 18 mm | In distribution |
| CES-384 | Length 400 mm | In distribution |
| CES-383 | Length 400 mm | In distribution |
| 6004-07-4 | Length 16 mm | In distribution |
| CES-376 | Length 400 mm | In distribution |
| 6009-10-7 | Length 16 mm | In distribution |
| CES-364 | Length 400 mm | In distribution |
| 6009-09-7 | Length 16 mm | In distribution |
| CES-374 | Length 400 mm | In distribution |
| CES-404 | Length 400 mm | In distribution |
| 6006-10-7 | Length 12 mm | In distribution |
| 6001-08-4 | Length 14 mm | In distribution |
| 6000-09-4 | Length 12 mm | In distribution |
| 6008-07-7 | Length 14 mm | In distribution |
| 6008-06-7 | Length 14 mm | In distribution |
| 6005-10-4 | Length 18 mm | In distribution |
| 6005-07-4 | Length 18 mm | In distribution |
| CES-359 | Length 400 mm | In distribution |
| 6001-05-4 | Length 14 mm | In distribution |
| CES-385 | Length 400 mm | In distribution |
| 6010-07-7 | Length 16 mm | In distribution |
| CES-378 | Length 400 mm | In distribution |
| 6004-08-4 | Length 16 mm | In distribution |
| CES-389 | Length 400 mm | In distribution |
| CES-371 | Length 400 mm | In distribution |
| CES-372 | Length 400 mm | In distribution |
| 6011-08-7 | Length 18 mm | In distribution |
| CES-388 | Length 400 mm | In distribution |
| 6010-09-7 | Length 16 mm | In distribution |
| 6010-05-7 | Length 16 mm | In distribution |
| CES-362 | Length 400 mm | In distribution |
| 6006-09-7 | Length 12 mm | In distribution |
| CES-392 | Length 400 mm | In distribution |
| 6000-08-4 | Length 12 mm | In distribution |
| 6003-10-4 | Length 16 mm | 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 |
|---|---|
| K250605 | 2025-03-12 |
| K180674 | 2018-06-25 |
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.