Hyper-C Anterior Cervical Plate System
Hyper-C is an anterior cervical plate-and-screw system for temporary stabilization while spinal fusion develops. Its plates connect to the vertebrae through bone screws placed from the…
Hyper-C is an anterior cervical plate-and-screw system for temporary stabilization while spinal fusion develops. Its plates connect to the vertebrae through bone screws placed from the front of the cervical spine.
Fixed-angle and variable-angle constructs are available, with self-tapping or self-drilling screw options. The implants use Ti-6Al-4V ELI titanium alloy.
Listed Item
Bone Screw, Self Drilling, 4.2 X 19 Variable
Levels and Supply
The system is intended for anterior intervertebral screw fixation from C2 to T1. Sterile and nonsterile versions are offered, with associated instruments for insertion and securing the construct. Its role is to support healing during cervical fusion.
14manufacturers in China registered for this device type
186catalogue numbers in this listing
3510(k) clearances naming this product code
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 | Degen Medical, United States |
|---|---|
| FDA product code | KWQ |
| Device type | Appliance, Fixation, Spinal Intervertebral Body |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3060 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K150759 |
| Record published | 2016-09-01 |
| Record revised | 2025-11-20 (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 |
| Sizes | Length 10 to 103 mm; outer diameter 4 to 4.6 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 0202-4219F | Outer Diameter 4.2 mm | In distribution |
| 0210-4080T | Length 80 mm | In distribution |
| 0201-4219V | Outer Diameter 4.2 mm | In distribution |
| 0201-4213V | Length 13 mm | In distribution |
| 0202-4013F | Outer Diameter 4 mm | In distribution |
| 0201-4215F | Length 15 mm | In distribution |
| 0204-4517F | Outer Diameter 4.6 mm | In distribution |
| 0201-4213F | Length 13 mm | In distribution |
| 0204-4518F | Length 18 mm | In distribution |
| 0201-4220F | Length 20 mm | In distribution |
| 0202-4216V | Outer Diameter 4.2 mm | In distribution |
| 0210-4068T | Length 68 mm | In distribution |
| 0203-4510V | Length 10 mm | In distribution |
| 0201-4012V | Outer Diameter 4 mm | In distribution |
| 0210-5088T | Length 88 mm | In distribution |
| 0210-4060T | Length 60 mm | In distribution |
| 0201-4013V | Length 13 mm | In distribution |
| 0201-4020V | Outer Diameter 4 mm | In distribution |
| 0210-4056T | Length 56 mm | In distribution |
| 0202-4217V | Outer Diameter 4.2 mm | In distribution |
| 0204-4516F | Outer Diameter 4.6 mm | In distribution |
| 0210-1012T | Length 12 mm | In distribution |
| 0202-4020V | Length 20 mm | In distribution |
| 0202-4210F | Outer Diameter 4.2 mm | In distribution |
| 0202-4015V | Length 15 mm | In distribution |
| 0203-4520F | Outer Diameter 4.6 mm | In distribution |
| 0202-4018V | Outer Diameter 4 mm | In distribution |
| 0202-4212F | Outer Diameter 4.2 mm | In distribution |
| 0210-4064T | Length 64 mm | In distribution |
| 0210-2034T | Length 34 mm | In distribution |
| 0202-4220F | Outer Diameter 4.2 mm | In distribution |
| 0204-4515F | Length 15 mm | In distribution |
| 0210-5093T | Length 93 mm | In distribution |
| 0210-3065T | Length 65 mm | In distribution |
| 0201-4217F | Outer Diameter 4.2 mm | In distribution |
| 0210-1023T | Length 23 mm | In distribution |
| 0210-5083T | Length 83 mm | In distribution |
| 0201-4210F | Length 10 mm | In distribution |
| 0210-2042T | Length 42 mm | In distribution |
| 0203-4511V | Outer Diameter 4.6 mm | In distribution |
| 0210-3053T | Length 53 mm | In distribution |
| 0201-4012F | Outer Diameter 4 mm | In distribution |
| 0203-4516V | Outer Diameter 4.6 mm | In distribution |
| 0202-4015F | Length 15 mm | In distribution |
| 0210-2023T | Length 23 mm | In distribution |
| 0202-4213F | Length 13 mm | In distribution |
| 0202-4220V | Outer Diameter 4.2 mm | In distribution |
| 0210-3056T | Length 56 mm | In distribution |
| 0202-4219V | Outer Diameter 4.2 mm | In distribution |
| 0210-1015T | Length 15 mm | In distribution |
| 0201-4215V | Outer Diameter 4.2 mm | In distribution |
| 0203-4513V | Outer Diameter 4.6 mm | In distribution |
| 0203-4513F | Outer Diameter 4.6 mm | In distribution |
| 0202-4014V | Length 14 mm | In distribution |
| 0201-4018F | Outer Diameter 4 mm | In distribution |
| 0201-4015V | Outer Diameter 4 mm | In distribution |
| 0210-2025T | Length 25 mm | In distribution |
| 0201-4211F | Outer Diameter 4.2 mm | In distribution |
| 0204-4516V | Length 16 mm | In distribution |
| 0202-4012F | Length 12 mm | In distribution |
| 0204-4513F | Length 13 mm | In distribution |
| 0210-5098T | Length 98 mm | In distribution |
| 0203-4520V | Length 20 mm | In distribution |
| 0204-4515V | Outer Diameter 4.6 mm | In distribution |
| 0201-4010V | Outer Diameter 4 mm | In distribution |
| 0204-4511F | Outer Diameter 4.6 mm | In distribution |
| 0202-4214V | Outer Diameter 4.2 mm | In distribution |
| 0202-4218F | Length 18 mm | In distribution |
| 0210-4076T | Length 76 mm | In distribution |
| 0201-4218F | Outer Diameter 4.2 mm | In distribution |
| 0202-4019F | Length 19 mm | In distribution |
| 0202-4013V | Outer Diameter 4 mm | In distribution |
| 0203-4519F | Outer Diameter 4.6 mm | In distribution |
| 0201-4016F | Outer Diameter 4 mm | In distribution |
| 0210-4052T | Length 52 mm | In distribution |
| 0202-4211F | Length 11 mm | In distribution |
| 0202-4012V | Outer Diameter 4 mm | In distribution |
| 0204-4513V | Outer Diameter 4.6 mm | In distribution |
| 0204-4517V | Outer Diameter 4.6 mm | In distribution |
| 0210-1027T | Length 27 mm | In distribution |
| 0202-4011F | Outer Diameter 4 mm | In distribution |
| 0203-4519V | Outer Diameter 4.6 mm | In distribution |
| 0201-4218V | Length 18 mm | In distribution |
| 0202-4010F | Outer Diameter 4 mm | In distribution |
| 0203-4514V | Outer Diameter 4.6 mm | In distribution |
| 0210-1025T | Length 25 mm | In distribution |
| 0202-4217F | Outer Diameter 4.2 mm | In distribution |
| 0210-3050T | Length 50 mm | In distribution |
| 0202-4019V | Length 19 mm | In distribution |
| 0201-4216F | Length 16 mm | In distribution |
| 0204-4510F | Outer Diameter 4.6 mm | In distribution |
| 0202-4212V | Outer Diameter 4.2 mm | In distribution |
| 0204-4520F | Outer Diameter 4.6 mm | In distribution |
| 0210-1013T | Length 13 mm | In distribution |
| 0210-2044T | Length 44 mm | In distribution |
| 0203-4517V | Length 17 mm | In distribution |
| 0202-4215V | Outer Diameter 4.2 mm | In distribution |
| 0203-4514F | Outer Diameter 4.6 mm | In distribution |
| 0210-3035T | Length 35 mm | In distribution |
| 0201-4019V | Outer Diameter 4 mm | In distribution |
| 0201-4015F | Outer Diameter 4 mm | In distribution |
| 0210-4088T | Length 88 mm | In distribution |
| 0202-4016F | Outer Diameter 4 mm | In distribution |
| 0210-2036T | Length 36 mm | In distribution |
| 0201-4019F | Length 19 mm | In distribution |
| 0201-4216V | Outer Diameter 4.2 mm | In distribution |
| 0210-2032T | Length 32 mm | In distribution |
| 0202-4210V | Outer Diameter 4.2 mm | In distribution |
| 0210-5078T | Length 78 mm | In distribution |
| 0202-4011V | Length 11 mm | In distribution |
| 0201-4210V | Outer Diameter 4.2 mm | In distribution |
| 0202-4010V | Outer Diameter 4 mm | In distribution |
| 0210-5103T | Length 103 mm | In distribution |
| 0210-5068T | Length 68 mm | In distribution |
| 0210-1011T | Length 11 mm | In distribution |
| 0210-2024T | Length 24 mm | In distribution |
| 0201-4018V | Outer Diameter 4 mm | In distribution |
| 0202-4014F | Outer Diameter 4 mm | In distribution |
| 0203-4517F | Outer Diameter 4.6 mm | In distribution |
| 0202-4215F | Outer Diameter 4.2 mm | In distribution |
| 0210-3038T | Length 38 mm | In distribution |
| 0210-3041T | Length 41 mm | In distribution |
| 0203-4512F | Outer Diameter 4.6 mm | In distribution |
| 0210-4072T | Length 72 mm | In distribution |
| 0210-5073T | Length 73 mm | In distribution |
| 0201-4217V | Length 17 mm | In distribution |
| 0210-3044T | Length 44 mm | In distribution |
| 0203-4516F | Length 16 mm | In distribution |
| 0202-4017F | Outer Diameter 4 mm | In distribution |
| 0203-4510F | Length 10 mm | In distribution |
| 0201-4017V | Length 17 mm | In distribution |
| 0201-4010F | Length 10 mm | In distribution |
| 0203-4515F | Outer Diameter 4.6 mm | In distribution |
| 0202-4211V | Length 11 mm | In distribution |
| 0201-4220V | Outer Diameter 4.2 mm | In distribution |
| 0201-4211V | Length 11 mm | In distribution |
| 0201-4014V | Length 14 mm | In distribution |
| 0210-2026T | Length 26 mm | In distribution |
| 0204-4510V | Outer Diameter 4.6 mm | In distribution |
| 0202-4218V | Length 18 mm | In distribution |
| 0210-1021T | Length 21 mm | In distribution |
| 0201-4011F | Outer Diameter 4 mm | In distribution |
| 0202-4213V | Length 13 mm | In distribution |
| 0203-4512V | Outer Diameter 4.6 mm | In distribution |
| 0204-4519F | Length 19 mm | In distribution |
| 0204-4519V | Outer Diameter 4.6 mm | In distribution |
| 0201-4212F | Outer Diameter 4.2 mm | In distribution |
| 0204-4512V | Outer Diameter 4.6 mm | In distribution |
| 0210-2022T | Length 22 mm | In distribution |
| 0210-4084T | Length 84 mm | In distribution |
| 0210-1014T | Length 14 mm | In distribution |
| 0201-4013F | Outer Diameter 4 mm | In distribution |
| 0201-4017F | Length 17 mm | In distribution |
| 0201-4011V | Length 11 mm | In distribution |
| 0202-4216F | Outer Diameter 4.2 mm | In distribution |
| 0203-4515V | Length 15 mm | In distribution |
| 0210-2028T | Length 28 mm | In distribution |
| 0210-3062T | Length 62 mm | In distribution |
| 0210-2040T | Length 40 mm | In distribution |
| 0201-4219F | Length 19 mm | In distribution |
| 0203-4518F | Length 18 mm | In distribution |
| 0202-4018F | Outer Diameter 4 mm | In distribution |
| 0210-1019T | Length 19 mm | In distribution |
| 0202-4017V | Length 17 mm | In distribution |
| 0204-4518V | Outer Diameter 4.6 mm | In distribution |
| 0201-4214V | Outer Diameter 4.2 mm | In distribution |
| 0210-1017T | Length 17 mm | In distribution |
| 0203-4511F | Outer Diameter 4.6 mm | In distribution |
| 0201-4214F | Outer Diameter 4.2 mm | In distribution |
| 0210-3047T | Length 47 mm | In distribution |
| 0210-2030T | Length 30 mm | In distribution |
| 0201-4014F | Length 14 mm | In distribution |
| 0202-4016V | Outer Diameter 4 mm | In distribution |
| 0204-4514V | Outer Diameter 4.6 mm | In distribution |
| 0202-4020F | Length 20 mm | In distribution |
| 0204-4520V | Outer Diameter 4.6 mm | In distribution |
| 0210-2038T | Length 38 mm | In distribution |
| 0204-4511V | Outer Diameter 4.6 mm | In distribution |
| 0202-4214F | Length 14 mm | In distribution |
| 0201-4016V | Length 16 mm | In distribution |
| 0210-3059T | Length 59 mm | In distribution |
| 0204-4512F | Length 12 mm | In distribution |
| 0203-4518V | Length 18 mm | In distribution |
| 0201-4020F | Outer Diameter 4 mm | In distribution |
| 0204-4514F | Outer Diameter 4.6 mm | In distribution |
| 0201-4212V | Outer Diameter 4.2 mm | 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 |
|---|---|
| K213901 | 2022-01-07 |
| K191786 | 2019-08-30 |
| K150759 | 2015-07-28 |
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.