Elegance® Anterior Cervical Plate
The self-drilling variable screw in the Elegance Anterior Cervical Plate range is a bone screw used with anterior cervical plates. The system fixes the cervical spine from C2 to C7, with…
The self-drilling variable screw in the Elegance Anterior Cervical Plate range is a bone screw used with anterior cervical plates. The system fixes the cervical spine from C2 to C7, with screws inserted into vertebral bodies through an anterior approach. Both the screws and plates are titanium alloy.
The plate family includes constructs spanning one to five levels, with rounded plate corners, screw holes and locking systems. Screw options include self-drilling or self-tapping designs and fixed or variable configurations. Selection depends on the required plate construct.
Listed Item
Elegance Variable Screw Self-Drilling
Cervical Fixation Applications
The system is indicated for degenerative disc disease confirmed by history and imaging, spondylolisthesis, spinal stenosis, deformities such as scoliosis or kyphosis, pseudoarthrosis and revision of earlier surgery. These are indications for the assembled cervical fixation system in which the screw is used.
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 | Clariance, Inc., United States |
|---|---|
| FDA product code | KWQ |
| Device type | Appliance, Fixation, Spinal Intervertebral Body |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3060 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K243904 |
| Record published | 2025-09-02 |
| Record revised | 2025-11-20 (version 2) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 53074014 | In distribution | |
| 53064512 | In distribution | |
| 53430240 | In distribution | |
| 53044014 | In distribution | |
| 53430580 | In distribution | |
| 53430110 | In distribution | |
| 53054014 | In distribution | |
| 53034018 | In distribution | |
| 53064014 | In distribution | |
| 53044516 | In distribution | |
| 53430108 | In distribution | |
| 53430220 | In distribution | |
| 53430236 | In distribution | |
| 53430113 | In distribution | |
| 53430224 | In distribution | |
| 53430120 | In distribution | |
| 53430359 | In distribution | |
| 53430476 | In distribution | |
| 53430122 | In distribution | |
| 53430230 | In distribution | |
| 53430114 | In distribution | |
| 53430112 | In distribution | |
| 53430468 | In distribution | |
| 53430234 | In distribution | |
| 53430356 | In distribution | |
| 53430353 | In distribution | |
| 53430115 | In distribution | |
| 53064016 | In distribution | |
| 53074012 | In distribution | |
| 53064516 | In distribution | |
| 53430464 | In distribution | |
| 53430484 | In distribution | |
| 53064514 | In distribution | |
| 53044018 | In distribution | |
| 53074016 | In distribution | |
| 53430511 | In distribution | |
| 53054016 | In distribution | |
| 53034016 | In distribution | |
| 53034012 | In distribution | |
| 53430341 | In distribution | |
| 53074018 | In distribution | |
| 53430350 | In distribution | |
| 53044514 | In distribution | |
| 53430118 | In distribution | |
| 53044512 | In distribution | |
| 53430116 | In distribution | |
| 53430238 | In distribution | |
| 53430362 | In distribution | |
| 53430510 | In distribution | |
| 53430472 | In distribution | |
| 53430338 | In distribution | |
| 53430347 | In distribution | |
| 53430111 | In distribution | |
| 53430460 | In distribution | |
| 53430228 | In distribution | |
| 53430590 | In distribution | |
| 53430480 | In distribution | |
| 53430226 | In distribution | |
| 53034014 | In distribution | |
| 53430344 | In distribution | |
| 53044518 | In distribution | |
| 53430222 | In distribution | |
| 53044012 | In distribution | |
| 53054012 | In distribution | |
| 53064012 | In distribution | |
| 53064518 | In distribution | |
| 53044016 | In distribution | |
| 53054018 | In distribution | |
| 53430232 | In distribution | |
| 53064018 | In distribution | |
| 53430109 | 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 |
|---|---|
| K243904 | 2025-01-14 |
| K220182 | 2022-03-30 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Clariance, Inc. | 510(k) number | 2026-02-20 | Class II | Process change control | Due to a quality issue regarding the presence of burr on the finished cervical plate product. | 511 |
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.