Skye Cervical Plate System
Dia 4.25mm x 18mm Variable
14manufacturers in China registered for this device type
64catalogue numbers in this listing
4510(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 | Evolution Spine, LLC, 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, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K173375 |
| Record published | 2021-06-02 |
| 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 |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Sizes | Length 10 to 110 mm; outer diameter 3.75 to 4.25 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CP683 | 3 Level | In distribution |
| CP482 | 2 Level | In distribution |
| CSV4218 | Variable | In distribution |
| CP1005 | 5 Level | In distribution |
| CP684 | 4 Level | In distribution |
| CP764 | Length 76 mm | In distribution |
| CP623 | 3 Level | In distribution |
| CP261 | Length 26 mm | In distribution |
| CP554 | Length 55 mm | In distribution |
| CSF4216 | Outer Diameter 4.25 mm | In distribution |
| CP181 | Length 18 mm | In distribution |
| CSF4212 | Fixed | In distribution |
| CP362 | 2 Level | In distribution |
| CSV3716 | Length 16 mm | In distribution |
| CSV3718 | Outer Diameter 3.75 mm | In distribution |
| CP644 | 4 Level | In distribution |
| CP141 | Length 14 mm | In distribution |
| CP504 | Length 50 mm | In distribution |
| CP713 | Length 71 mm | In distribution |
| CP905 | 5 Level | In distribution |
| CSF3712 | Outer Diameter 3.75 mm | In distribution |
| CP955 | Length 95 mm | In distribution |
| CSV3712 | Length 12 mm | In distribution |
| CSV4214 | Outer Diameter 4.25 mm | In distribution |
| CP1105 | Length 110 mm | In distribution |
| CP844 | Length 84 mm | In distribution |
| CP282 | 2 Level | In distribution |
| CP593 | Length 59 mm | In distribution |
| CP221 | 1 Level | In distribution |
| CP724 | Length 72 mm | In distribution |
| CP804 | 4 Level | In distribution |
| CP332 | 2 Level | In distribution |
| CP473 | Length 47 mm | In distribution |
| CP503 | Length 50 mm | In distribution |
| CSF4214 | Fixed | In distribution |
| CP302 | Length 30 mm | In distribution |
| CP533 | Length 53 mm | In distribution |
| CP443 | 3 Level | In distribution |
| CP755 | Length 75 mm | In distribution |
| CP241 | Length 24 mm | In distribution |
| CP653 | Length 65 mm | In distribution |
| CP161 | Length 16 mm | In distribution |
| CSF3716 | Length 16 mm | In distribution |
| CSF3714 | Outer Diameter 3.75 mm | In distribution |
| CP101 | Length 10 mm | In distribution |
| CSF4218 | Fixed | In distribution |
| CP281 | Length 28 mm | In distribution |
| CP805 | 5 Level | In distribution |
| CP262 | Length 26 mm | In distribution |
| CSV3714 | Variable | In distribution |
| CSV4216 | Outer Diameter 4.25 mm | In distribution |
| CP855 | Length 85 mm | In distribution |
| CP242 | Length 24 mm | In distribution |
| CP121 | Length 12 mm | In distribution |
| CP563 | 3 Level | In distribution |
| CP201 | Length 20 mm | In distribution |
| CP1055 | Length 105 mm | In distribution |
| CP392 | 2 Level | In distribution |
| CP413 | Length 41 mm | In distribution |
| CP422 | Length 42 mm | In distribution |
| CP604 | Length 60 mm | In distribution |
| CSF3718 | Outer Diameter 3.75 mm | In distribution |
| CSV4212 | Outer Diameter 4.25 mm | In distribution |
| CP452 | 2 Level | 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 |
|---|---|
| K220275 | 2022-03-18 |
| K212405 | 2021-09-30 |
| K180755 | 2018-07-06 |
| K173375 | 2017-12-21 |
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.