GSO ACP1 Anterior Cervical Plate System
Variable Angle Screw
14manufacturers in China registered for this device type
56catalogue numbers in this listing
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 | Unified 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, Manufacturer |
| Record published | 2016-09-15 |
| Record revised | 2025-11-20 (version 6) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 509472 | 72mm Overall Length 4 Level Plate | In distribution |
| 509132 | 32mm Overall Length 1 Level Plate | In distribution |
| 509128 | 28mm Overall Length 1 Level Plate | In distribution |
| 509252 | 52mm Overall Length 2 Level Plate | In distribution |
| 509126 | 26mm Overall Length 1 Level Plate | In distribution |
| 509368 | 68mm Overall Length 3 Level Plate | In distribution |
| 509484 | 84mm Overall Length 4 Level Plate | In distribution |
| 509356 | 56mm Overall Length 3 Level Plate | In distribution |
| 509234 | 34mm Overall Length 2 Level Plate | In distribution |
| 509243 | 43mm Overall Length 2 Level Plate | In distribution |
| 509377 | 77mm Overall Length 3 Level Plate | In distribution |
| 509314 | 4.5mm x 14mm Fixed Angle Screw | In distribution |
| 509310 | 4.5mm x 10mm Fixed Angle Screw | In distribution |
| 509512 | 4.5mm x 12mm Variable Angle Screw | In distribution |
| 509488 | 88mm Overall Length 4 Level Plate | In distribution |
| 509499 | 100mm Overall Length 4 Level Plate | In distribution |
| 509516 | 4.5mm x 16mm Variable Angle Screw | In distribution |
| 509416 | 4.0mm x 16mm Variable Angle Screw | In distribution |
| 509122 | 22mm Overall Length 1 Level Plate | In distribution |
| 509130 | 30mm Overall Length 1 Level Plate | In distribution |
| 509414 | 4.0mm x 14mm Variable Angle Screw | In distribution |
| 509210 | 4.0mm X 10mm Fixed Angle Screw | In distribution |
| 509412 | 4.0mm x 12mm Variable Angle Screw | In distribution |
| 509359 | 59mm Overall Length 3 Level Plate | In distribution |
| 509518 | 4.5mm x 18mm Variable Angle Screw | In distribution |
| 509520 | 4.5mm x 20mm Variable Angle Screw | In distribution |
| 509371 | 71mm Overall Length 3 Level Plate | In distribution |
| 509353 | 53mm Overall Length 3 Level Plate | In distribution |
| 509362 | 62mm Overall Length 3 Level Plate | In distribution |
| 509124 | 24mm Overall Length 1 Level Plate | In distribution |
| 509214 | 4.0mm x 14mm Fixed Angle Screw | In distribution |
| 509410 | 4.0mm x 10mm Variable Angle Screw | In distribution |
| 509218 | 4.0mm x 18mm Fixed Angle Screw | In distribution |
| 509480 | 80mm Overall Length 4 Level Plate | In distribution |
| 509496 | 96mm Overall Length 4 Level Plate | In distribution |
| 509514 | 4.5mm x 14mm Variable Angle Screw | In distribution |
| 509316 | 4.5mm x 16mm Fixed Angle Screw | In distribution |
| 509420 | 4.0mm x 20mm Variable Angle Screw | In distribution |
| 509246 | 46mm Overall Length 2 Level Plate | In distribution |
| 509468 | 68mm Overall Length 4 Level Plate | In distribution |
| 509374 | 74mm Overall Length 3 Level Plate | In distribution |
| 509216 | 4.0mm x 16mm Fixed Angle Screw | In distribution |
| 509320 | 4.5mm x 20mm Fixed Angle Screw | In distribution |
| 509312 | 4.5mm x 12mm Fixed Angle Screw | In distribution |
| 509476 | 76mm Overall Length 4 Level Plate | In distribution |
| 509249 | 49mm Overall Length 2 Level Plate | In distribution |
| 509237 | 37mm Overall Length 2 Level Plate | In distribution |
| 509240 | 40mm Overall Length 2 Level Plate | In distribution |
| 509120 | 20mm Overall Length 1 Level Plate | In distribution |
| 509212 | 4.0mm x 12mm Fixed Angle Screw | In distribution |
| 509220 | 4.0mm x 20mm Fixed Angle Screw | In distribution |
| 509492 | 92mm Overall Length 4 Level Plate | In distribution |
| 509318 | 4.5mm x 18mm Fixed Angle Screw | In distribution |
| 509418 | 4.0mm x 18mm Variable Angle Screw | In distribution |
| 509510 | 4.5mm x 10mm Variable Angle Screw | In distribution |
| 509365 | 65mm Overall Length 3 Level Plate | 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
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.