CarboClear Cervical Plate System
CarboClear Cervical Plate System provides anterior fixation of the cervical spine while a fusion develops. It combines plates, screws and instruments in a range of dimensions. The plates…
CarboClear Cervical Plate System provides anterior fixation of the cervical spine while a fusion develops. It combines plates, screws and instruments in a range of dimensions.
The plates are carbon-fiber-reinforced PEEK, while the screws are titanium alloy. These different materials belong to different components of the construct.
Listed Item
Following screw hole preparation, where applicable, the gauge may be used to measure depth and to confirm appropriate screw selection.
Plate Configurations
Cervical plates may incorporate tantalum markers. Plate and screw dimensions vary across the family, allowing different implant configurations for cervical stabilization. The accompanying instruments form the preparation and placement side of the system.
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 | CarboFix Orthopedics, Ltd., Israel |
|---|---|
| FDA product code | KWQ |
| Device type | Appliance, Fixation, Spinal Intervertebral Body |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3060 |
| Establishment | Manufacturer |
| 510(k) | K200883 |
| Record published | 2020-06-09 |
| Record revised | 2025-02-06 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Sizes | Length 10 to 115 mm; outer diameter 2.5 to 4.5 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Self-Drilling Screw, Ø4mm x 16mm | Outer Diameter 4 mm | In distribution |
| Cervical Plate 1 level 24 mm | Length 24 mm | In distribution |
| Cervical Plate Drill Bit 16mm | Outer Diameter 2.5 mm | In distribution |
| Cervical Plate 4 levels 76 mm | Length 76 mm | In distribution |
| Cervical Plate 4 levels 68 mm | Length 68 mm | In distribution |
| Cervical Plate Screwdriver Hex 1.5 Bit | In distribution | |
| Cervical Plate Drill Bit Ø2.5mm | In distribution | |
| Cervical Plate 2 levels 39 mm | Length 39 mm | In distribution |
| Cervical Plate Holder – Inner Rod | In distribution | |
| Cervical Plate 1 level 22 mm | Length 22 mm | In distribution |
| Cervical Plate 4 levels 84 mm | Length 84 mm | In distribution |
| Cervical Plate 4 levels 72 mm | Length 72 mm | In distribution |
| Cervical Plate 3 levels 62 mm | Length 62 mm | In distribution |
| Cervical Plate 4 levels 60 mm | Length 60 mm | In distribution |
| Cervical Plate 1 level 26 mm | Length 26 mm | In distribution |
| Cervical Plate 3 levels 50 mm | Length 50 mm | In distribution |
| Cervical Plate Screw Depth Gauge | In distribution | |
| Cervical Plate Drill Bit 20mm | Outer Diameter 2.5 mm | In distribution |
| Cervical Plate 2 levels 41.5 mm | Length 41.5 mm | In distribution |
| Cervical Plate Drill Guide | In distribution | |
| Self-Drilling Screw, Ø4mm x 14mm | Length 14 mm | In distribution |
| Patient Specific Cervical Plate | In distribution | |
| Cervical Plate 3 levels 47 mm | Length 47 mm | In distribution |
| Self-Drilling Screw, Ø4mm x 18mm | Outer Diameter 4 mm | In distribution |
| Self-Tapping Screw, Ø4.5mm x 14mm | Outer Diameter 4.5 mm | In distribution |
| Cervical Plate 3 levels 59 mm | Length 59 mm | In distribution |
| Cervical Plate Drill Bit Ø3mm | In distribution | |
| Self-Tapping Screw, Ø4.5mm x 20mm | Outer Diameter 4.5 mm | In distribution |
| Self-Tapping Screw, Ø4.5mm x 18mm | Outer Diameter 4.5 mm | In distribution |
| Cervical Plate Drill Bit 18mm | Outer Diameter 2.5 mm | In distribution |
| Cervical Plate 4 levels 64 mm | Length 64 mm | In distribution |
| Cervical Plate 2 levels 31.5 mm | Length 31.5 mm | In distribution |
| Cervical Plate 3 levels 44 mm | Length 44 mm | In distribution |
| Self-Drilling Screw, Ø4mm x 12mm | Length 12 mm | In distribution |
| Self-Tapping Screw, Ø4.5mm x 12mm | Outer Diameter 4.5 mm | In distribution |
| Cervical Plate Holder -Outer Part | In distribution | |
| Cervical Plate 2 levels 44 mm | Length 44 mm | In distribution |
| Cervical Plate Drill Bit 14mm | Outer Diameter 2.5 mm | In distribution |
| Cervical Plate Holder | In distribution | |
| Cervical Plate 2 levels 36.5 mm | Length 36.5 mm | In distribution |
| Self-Tapping Screw, Ø4.5mm x 16mm | Outer Diameter 4.5 mm | In distribution |
| Cervical Plate 3 levels 53 mm | Length 53 mm | In distribution |
| Cervical Plate Pre-Fixation Pin | In distribution | |
| Cervical Plate 1 level 28 mm | Length 28 mm | In distribution |
| Cervical Plate 2 levels 34 mm | Length 34 mm | In distribution |
| Cervical Plate 4 levels 80 mm | Length 80 mm | In distribution |
| Cervical Plate 3 levels 65 mm | Length 65 mm | In distribution |
| Cervical Plate Awl | In distribution | |
| Self-Tapping Screw, Ø4.5mm x 10mm | Length 10 mm | In distribution |
| Cervical Plate 4 levels 88 mm | Length 88 mm | In distribution |
| Self-Drilling Screw, Ø4mm x 20mm | Outer Diameter 4 mm | In distribution |
| Cervical Plate Drill Bit 12mm | Outer Diameter 2.5 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 |
|---|---|
| K200883 | 2020-06-04 |
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.