Aggeris™-C
Aggeris-C is an anterior cervical plate-and-screw system for fixation from C2 to C7. Its titanium-alloy plates have rounded corners, bone-screw holes and a screw-locking system. Plate…
Aggeris-C is an anterior cervical plate-and-screw system for fixation from C2 to C7. Its titanium-alloy plates have rounded corners, bone-screw holes and a screw-locking system.
Plate lengths accommodate treatment across one to five levels, with screws and plate dimensions selected for the reconstruction. Both plates and bone screws use titanium alloy conforming to ASTM F136.
Listed Item
AGGERIS-C VARIABLE SCREW Diameter 4.0x14MM SELF-DRILLING
Preparation and Construct
The system is supplied nonsterile for preparation and sterilization by the user. Its plates and locking screws form the anterior fixation construct for the cervical spine, with instruments used to place and secure the components.
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) | K220182 |
| Record published | 2022-05-08 |
| Record revised | 2025-11-20 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 43430110 | In distribution | |
| 43044520 | In distribution | |
| 43430338 | In distribution | |
| 43430122 | In distribution | |
| 43430472 | In distribution | |
| 43430236 | In distribution | |
| 43064018 | In distribution | |
| 43064016 | In distribution | |
| 43054016 | In distribution | |
| 43430114 | In distribution | |
| 43430344 | In distribution | |
| 43731000 | In distribution | |
| 43044518 | In distribution | |
| 43700220 | In distribution | |
| 43710018 | In distribution | |
| 43706001 | In distribution | |
| 43430362 | In distribution | |
| 43430238 | In distribution | |
| 43064010 | In distribution | |
| 43064012 | In distribution | |
| 43034014 | In distribution | |
| 43430118 | In distribution | |
| 43044010 | In distribution | |
| 43054012 | In distribution | |
| 43715001 | In distribution | |
| 43430232 | In distribution | |
| 43064516 | In distribution | |
| 43430590 | In distribution | |
| 43054018 | In distribution | |
| 43064520 | In distribution | |
| 43700214 | In distribution | |
| 43430112 | In distribution | |
| 43044016 | In distribution | |
| 43034012 | In distribution | |
| 43430228 | In distribution | |
| 43701035 | In distribution | |
| 43064514 | In distribution | |
| 43701040 | In distribution | |
| 43702002 | In distribution | |
| 43702001 | In distribution | |
| 43034016 | In distribution | |
| 43430224 | In distribution | |
| 43706003 | In distribution | |
| 43044512 | In distribution | |
| 43430484 | In distribution | |
| 43034018 | In distribution | |
| 43430580 | In distribution | |
| 43700218 | In distribution | |
| 43430234 | In distribution | |
| 43430240 | In distribution | |
| 43430350 | In distribution | |
| 43430347 | In distribution | |
| 43044516 | In distribution | |
| 43044020 | In distribution | |
| 43430353 | In distribution | |
| 43044510 | In distribution | |
| 43430113 | In distribution | |
| 43430468 | In distribution | |
| 43054014 | In distribution | |
| 43044514 | In distribution | |
| 43430341 | In distribution | |
| 43044012 | In distribution | |
| 43430226 | In distribution | |
| 43054020 | In distribution | |
| 43064020 | In distribution | |
| 43064014 | In distribution | |
| 43430356 | In distribution | |
| 43430116 | In distribution | |
| 43430476 | In distribution | |
| 43430109 | In distribution | |
| 43713001 | In distribution | |
| 43064510 | In distribution | |
| 43064512 | In distribution | |
| 43430230 | In distribution | |
| 43430460 | In distribution | |
| 43700212 | In distribution | |
| 43430120 | In distribution | |
| 43064518 | In distribution | |
| 43430222 | In distribution | |
| 43430464 | In distribution | |
| 43430111 | In distribution | |
| 43430480 | In distribution | |
| 43430510 | In distribution | |
| 43710017 | In distribution | |
| 43700216 | In distribution | |
| 43700210 | In distribution | |
| 43430220 | In distribution | |
| 43713002 | In distribution | |
| 43430115 | In distribution | |
| 43044018 | In distribution | |
| 43430108 | In distribution | |
| 43719003 | In distribution | |
| 43034020 | In distribution | |
| 43750001 | In distribution | |
| 43430359 | In distribution | |
| 43044014 | 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
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 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.