SureMAX-X
SureMAX-X is an additively manufactured cervical interbody spacer for anterior fusion in skeletally mature patients. It is used for cervical disc degeneration or instability associated with…
SureMAX-X is an additively manufactured cervical interbody spacer for anterior fusion in skeletally mature patients. It is used for cervical disc degeneration or instability associated with radiculopathy, myelopathy or pain at multiple contiguous levels from C2 to T1, after at least six weeks of nonoperative treatment.
The implant has a keystone shape and open architecture, with height, width, length and angulation options to accommodate patient anatomy. It is manufactured from Ti-6Al-4V ELI titanium alloy and supplied sterile.
Listed Item
SureMAX-X Cervical Spacer, 14° Hyperlordotic Extra-Large (15mm x 20mm) x 6mm
Graft and Fixation
The spacer is used with cancellous or corticocancellous autograft, allograft or both, and requires supplemental fixation. Hyperlordotic implants with an angle of 10 degrees or greater, including the listed 14-degree spacer, require an anterior cervical plate.
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 | Additive Implants, 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) | K193359 |
| Record published | 2020-03-04 |
| Record revised | 2025-07-14 (version 2) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Sizes | Angle 7 to 14 °; depth 12 to 15 mm; width 14 to 20 mm; height 5 to 9 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1 | Angle 10 ° | In distribution |
| 1 | Angle 7 ° | In distribution |
| 1 | Angle 7 ° | In distribution |
| 1 | Angle 14 ° | In distribution |
| 1 | Angle 14 ° | In distribution |
| 1 | Angle 7 ° | In distribution |
| 1 | Angle 10 ° | In distribution |
| 1 | Angle 10 ° | In distribution |
| 1 | Angle 7 ° | In distribution |
| 1 | Angle 14 ° | In distribution |
| 1 | Angle 10 ° | In distribution |
| 1 | Angle 7 ° | In distribution |
| 1 | Angle 14 ° | In distribution |
| 1 | Angle 7 ° | In distribution |
| 1 | Angle 7 ° | In distribution |
| 1 | Angle 10 ° | In distribution |
| 1 | Angle 14 ° | In distribution |
| 1 | Depth 15 mm | In distribution |
| 1 | Angle 14 ° | In distribution |
| 1 | Angle 14 ° | In distribution |
| 1 | Angle 14 ° | In distribution |
| 1 | Angle 7 ° | In distribution |
| 1 | Angle 10 ° | In distribution |
| 1 | Angle 14 ° | In distribution |
| 1 | Angle 10 ° | In distribution |
| 1 | Angle 14 ° | In distribution |
| 1 | Angle 10 ° | In distribution |
| 1 | Angle 14 ° | In distribution |
| 1 | Angle 10 ° | In distribution |
| 1 | Angle 14 ° | In distribution |
| 1 | Angle 7 ° | In distribution |
| 1 | Angle 7 ° | In distribution |
| 1 | Angle 10 ° | In distribution |
| 1 | Angle 7 ° | In distribution |
| 1 | Angle 14 ° | In distribution |
| 1 | Angle 10 ° | In distribution |
| 1 | Angle 14 ° | In distribution |
| 1 | Angle 7 ° | In distribution |
| 1 | Angle 7 ° | In distribution |
| 1 | Angle 7 ° | In distribution |
| 1 | Angle 7 ° | In distribution |
| 1 | Angle 10 ° | In distribution |
| 1 | Angle 10 ° | In distribution |
| 1 | Angle 10 ° | In distribution |
| 1 | Angle 10 ° | In distribution |
| 1 | Angle 10 ° | In distribution |
| 1 | Angle 7 ° | In distribution |
| 1 | Angle 14 ° | In distribution |
| 1 | Angle 14 ° | In distribution |
| 1 | Angle 10 ° | In distribution |
| 1 | Angle 14 ° | In distribution |
| 1 | Angle 7 ° | In distribution |
| 1 | Angle 10 ° | In distribution |
| 1 | Angle 14 ° | In distribution |
| 1 | Angle 14 ° | In distribution |
| 1 | Angle 10 ° | In distribution |
| 1 | Angle 7 ° | In distribution |
| 1 | Angle 10 ° | In distribution |
| 1 | Angle 7 ° | In distribution |
| 1 | Angle 14 ° | 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 |
|---|---|
| K193359 | 2020-01-03 |
| K182477 | 2019-01-28 |
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.