Mediant Anterior Cervical Plate
Mediant is an anterior cervical fixation system of titanium-alloy plates and bone screws. A plate is positioned against the front of the cervical vertebrae and fixed through its end holes…
Mediant is an anterior cervical fixation system of titanium-alloy plates and bone screws. A plate is positioned against the front of the cervical vertebrae and fixed through its end holes to stabilize the operative site during fusion.
The screws allow angular placement within 18 degrees of the plate’s nominal direction. A sliding mechanism, operated with locking pliers, secures the screws to the plate at the insertion angle.
Listed Item
Mediant 4.5 x 12 mm Bone Screw
Plate and Screw Range
Plates cover one, two or three cervical levels, with lengths from 19 to 78 mm. The system accepts 4.0 and 4.5 mm bone screws in different lengths. Implant components are Ti-6Al-4V ELI titanium alloy, and the intended cervical region extends from C2 to T1.
Who Else Makes It
Concentrated in Jiangsu (5), Shanghai (3), Zhejiang (2). 8 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| APS Materials Suzhou | Suzhou | Jiangsu | Contract manufacturer | 18 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
| Double Medical Technology Inc. | Xiamen | Fujian | Contract manufacturer | 14 |
Showing 12 of 14. All 14 manufacturers in China registered for Appliance, Fixation, Spinal Intervertebral Body
Record
| Listed by | Intelligent Implant Systems, LLC, United States |
|---|---|
| FDA product code | KWQ |
| Device type | Appliance, Fixation, Spinal Intervertebral Body |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3060 |
| 510(k) | K173935 |
| Record published | 2018-05-17 |
| Record revised | 2025-11-20 (version 4) |
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, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1214512 | In distribution | |
| 12101026 | In distribution | |
| 12102037 | In distribution | |
| 1214010 | In distribution | |
| 12103057 | In distribution | |
| 12103069 | In distribution | |
| 1214516 | In distribution | |
| 12101034 | In distribution | |
| 1214514 | In distribution | |
| 12102052 | In distribution | |
| 12101036 | In distribution | |
| 12101032 | In distribution | |
| 12101019 | In distribution | |
| 12101022 | In distribution | |
| 1214016 | In distribution | |
| 1214014 | In distribution | |
| 12103054 | In distribution | |
| 12103063 | In distribution | |
| 12103060 | In distribution | |
| 12101020 | In distribution | |
| 12103072 | In distribution | |
| 1214510 | In distribution | |
| 1214012 | In distribution | |
| 12102040 | In distribution | |
| 12101024 | In distribution | |
| 12102043 | In distribution | |
| 12102046 | In distribution | |
| 12101030 | In distribution | |
| 12102049 | In distribution | |
| 12103075 | In distribution | |
| 12103066 | In distribution | |
| 1214018 | In distribution | |
| 12101028 | In distribution | |
| 12102055 | In distribution | |
| 12103078 | In distribution | |
| 1214518 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| ReLine | Nuvasive, Inc. | 2,998 |
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 2,568 |
| Creo | Globus Medical, Inc. | 1,765 |
| AccelFix Spinal Fixation System | L&K Biomed Co., Ltd. | 1,755 |
| Ozark Cervical Plate System | VB Spine LLC | 1,460 |
| Sirion | Astura Medical | 1,246 |
| Apex Spine System | Spinecraft LLC | 1,187 |
| AnyPlus Spinal Fixation System | GS Medical Co., Ltd. | 986 |
| Astra Spine System | Spinecraft LLC | 970 |
| Zavation | Zavation | 966 |
| ACP | Nuvasive, Inc. | 918 |
| Polaris™ 5.5 Spinal System | Biomet Spine | 877 |
Showing 12 of 855. All products under Appliance, Fixation, Spinal Intervertebral Body
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K173935 | 2018-04-16 |
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.