Blue Mountain Cervical Plate System
Blue Mountain is an anterior cervical plate system that stabilizes the front of the neck portion of the spine while fusion develops. The plate is secured by screws to the vertebral bodies…
Blue Mountain is an anterior cervical plate system that stabilizes the front of the neck portion of the spine while fusion develops. The plate is secured by screws to the vertebral bodies from C2 through C7.
The system includes titanium alloy plates and screws in different sizes. The plates follow the curves of the cervical spine, while the choice of plate and screw size accommodates differences in patient anatomy.
Listed Item
CERVICAL CENTRAL SCREW Ø:4,5 L:18mm
Component Roles
The plate spans the vertebrae being stabilized, and its screws anchor the construct to the vertebral bodies. These components work together as fixation used during cervical fusion; a screw entry represents one part of the plate 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 | Spineway SA, France |
|---|---|
| FDA product code | KWQ |
| Device type | Appliance, Fixation, Spinal Intervertebral Body |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3060 |
| 510(k) | K150036 |
| Record published | 2016-09-12 |
| Record revised | 2025-02-06 (version 9) |
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 |
| Sizes | Length 12 to 93 mm; outer diameter 4 to 4.5 mm |
| Distribution end date | 2021-12-31 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 2 | Length 66 mm | In distribution | |
| 1 | Length 16 mm | 2 | In distribution |
| 2 | Length 62 mm | In distribution | |
| 1 | Length 18 mm | 2 | In distribution |
| 1 | Length 12 mm | 2 | In distribution |
| 2 | Length 87 mm | In distribution | |
| 1 | Length 20 mm | 2 | In distribution |
| 1 | Length 12 mm | 2 | In distribution |
| 1 | Length 16 mm | 2 | In distribution |
| 2 | Length 84 mm | In distribution | |
| 2 | Length 24 mm | In distribution | |
| 1 | Length 18 mm | 2 | In distribution |
| 1 | Length 20 mm | 2 | In distribution |
| 2 | Length 93 mm | In distribution | |
| 2 | Length 56 mm | In distribution | |
| 1 | Length 14 mm | 2 | In distribution |
| 1 | Length 18 mm | 2 | In distribution |
| 2 | Length 54 mm | In distribution | |
| 2 | Length 50 mm | In distribution | |
| 2 | Length 81 mm | In distribution | |
| 2 | Length 27 mm | In distribution | |
| 2 | Length 72 mm | In distribution | |
| 1 | Length 16 mm | 2 | In distribution |
| 2 | Length 41 mm | In distribution | |
| 2 | Length 34 mm | In distribution | |
| 2 | Length 52 mm | In distribution | |
| 2 | Length 78 mm | In distribution | |
| 1 | Length 12 mm | 2 | In distribution |
| 1 | Length 14 mm | 2 | In distribution |
| 1 | Length 14 mm | 2 | In distribution |
| 1 | Outer Diameter 4.5 mm | 2 | In distribution |
| 2 | Length 75 mm | In distribution | |
| 2 | Length 46 mm | In distribution | |
| 2 | Length 90 mm | In distribution | |
| 2 | Length 38 mm | In distribution | |
| 2 | Length 58 mm | In distribution | |
| 2 | Length 31 mm | In distribution | |
| 2 | Length 36 mm | In distribution | |
| 1 | Length 18 mm | 2 | In distribution |
| 2 | Length 43 mm | In distribution | |
| 2 | Length 29 mm | In distribution | |
| 1 | Length 16 mm | 2 | In distribution |
| 2 | Length 48 mm | In distribution | |
| 2 | Length 69 mm | In distribution | |
| 1 | 4 | Withdrawn | |
| 1 | Length 14 mm | 2 | Withdrawn |
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 |
|---|---|
| K150036 | 2015-05-07 |
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.