Pinehurst Anterior Cervical Plate System
The Pinehurst Anterior Cervical Plate System provides temporary supplemental fixation during cervical fusion from C2 to C7. It attaches to the front of the spine with plates and screws to…
The Pinehurst Anterior Cervical Plate System provides temporary supplemental fixation during cervical fusion from C2 to C7. It attaches to the front of the spine with plates and screws to immobilize and stabilize the treated segments.
Titanium alloy plates are available for one to four level fusion configurations. Each plate uses at least four screws and has an integrated locking mechanism to resist screw backout. Plates and screws are supplied sterile.
Clinical Indications
Indications include degenerative disc disease, spondylolisthesis, trauma, tumors, deformity, pseudarthrosis, failed previous fusion and spinal stenosis. The system serves as an adjunct to fusion, with plate configuration selected for the levels requiring treatment.
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 | Signature Orthopaedics PTY Limited, Australia |
|---|---|
| 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, Complaint-file establishment, Manufacturer |
| 510(k) | K181190 |
| Record published | 2019-02-19 |
| Record revised | 2025-11-20 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PS1-16-1022 | In distribution | |
| PS1-16-3057 | In distribution | |
| PS1-16-3048 | In distribution | |
| PS1-16-1014 | In distribution | |
| PS1-16-2044 | In distribution | |
| PS1-16-2038 | In distribution | |
| PS1-16-1028 | In distribution | |
| PS1-16-1016 | In distribution | |
| PS1-16-6216 | In distribution | |
| PS1-16-6214 | In distribution | |
| PS1-16-3054 | In distribution | |
| PS1-16-2032 | In distribution | |
| PS1-16-6316 | In distribution | |
| PS1-16-1030 | In distribution | |
| PS1-16-6320 | In distribution | |
| PS1-16-3060 | In distribution | |
| PS1-16-6218 | In distribution | |
| PS1-16-2030 | In distribution | |
| PS1-16-3051 | In distribution | |
| PS1-16-3045 | In distribution | |
| PS1-16-2040 | In distribution | |
| PS1-16-4088 | In distribution | |
| PS1-16-2036 | In distribution | |
| PS1-16-4076 | In distribution | |
| PS1-16-4072 | In distribution | |
| PS1-16-6312 | In distribution | |
| PS1-16-1012 | In distribution | |
| PS1-16-1020 | In distribution | |
| PS1-16-1026 | In distribution | |
| PS1-16-6220 | In distribution | |
| PS1-16-6318 | In distribution | |
| PS1-16-2034 | In distribution | |
| PS1-16-4084 | In distribution | |
| PS1-16-1018 | In distribution | |
| PS1-16-3063 | In distribution | |
| PS1-16-2042 | In distribution | |
| PS1-16-1024 | In distribution | |
| PS1-16-4064 | In distribution | |
| PS1-16-3042 | In distribution | |
| PS1-16-3066 | In distribution | |
| PS1-16-4080 | In distribution | |
| PS1-16-6212 | In distribution | |
| PS1-16-6314 | In distribution | |
| PS1-16-4068 | 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 |
|---|---|
| K181190 | 2019-01-17 |
| K163625 | 2017-08-11 |
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.