GSO GS1 Spinal System
Set Screw for 5mm Rod System
11manufacturers in China registered for this device type
46catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (5), Shandong (2), Shanghai (1). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| 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 |
| 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 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
| Double Medical Technology Inc. | Xiamen | Fujian | Contract manufacturer | 14 |
| Zhejiang Decans Medical Devices Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 10 |
Record
| Listed by | Unified Spine, LLC, United States |
|---|---|
| FDA product code | KWP |
| Device type | Appliance, Fixation, Spinal Interlaminal |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3050 |
| Establishment | Specification developer, Manufacturer |
| Record published | 2016-09-16 |
| Record revised | 2025-07-14 (version 8) |
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 |
|---|---|---|
| 501740 | 7.5mm x 40mm Multi-Directional Screw | In distribution |
| 501214 | Large Standard Tip Hook for 5.5mm Rod | In distribution |
| 501217 | Wide Tip Hook for 5.5mm Rod, Large | In distribution |
| 501735 | 7.5mm x 35mm Multi-Directional Screw | In distribution |
| 502240 | 40-50mm Adj. Cross-Connector | In distribution |
| 501750 | 7.5mm x 50mm Multi-Directional Screw | In distribution |
| 502260 | 60-70mm Adj. Cross-Connector | In distribution |
| 501630 | 6.5mm x 30mm Multi-Directional Screw | In distribution |
| 501535 | 5.5mm x 35mm Multi-Directional Screw | In distribution |
| 501220 | Large Narrow Tip Hook for 5.5mm Rod | In distribution |
| 501775 | 7.5mm x 75mm Multi-Directional Screw | In distribution |
| 501530 | 5.5mm x 30mm Multi-Directional Screw | In distribution |
| 501222 | Medium Split Tip Hook for 5.5mm Rod | In distribution |
| 501216 | Wide Tip Hook for 5.5mm Rod, Medium | In distribution |
| 501730 | 7.5mm x 30mm Multi-Directional Screw | In distribution |
| 501650 | 6.5mm x 50mm Multi-Directional Screw | In distribution |
| 501223 | Large Split Tip Hook for 5.5mm Rod | In distribution |
| 501660 | 6.5mm x 60mm Multi-Directional Screw | In distribution |
| 501525 | 5.5mm x 25mm Multi-Directional Screw | In distribution |
| 501219 | Medium Narrow Tip Hook for 5.5mm Rod | In distribution |
| 501125 | 3/8 inch -16 Class 3, 3 degree/45 degree Buttress Thread | In distribution |
| 501635 | 6.5mm x 35mm Multi-Directional Screw | In distribution |
| 502100 | 5.5mm x 20″ Rod | In distribution |
| 501645 | 6.5mm x 45mm Multi-Directional Screw | In distribution |
| 501745 | 7.5mm x 45mm Multi-Directional Screw | In distribution |
| 501550 | 5.5mm x 50mm Multi-Directional Screw | In distribution |
| 502230 | 30-40mm Adj. Cross-Connector | In distribution |
| 501221 | Small Split Tip Hook for 5.5mm Rod | In distribution |
| 501780 | 7.5mm x 80mm Multi-Directional Screw | In distribution |
| 501625 | 6.5mm x 25mm Multi-Directional Screw | In distribution |
| 502250 | 50-60mm Adj. Cross-Connector | In distribution |
| 501555 | 5.5mm x 55mm Multi-Directional Screw | In distribution |
| 501755 | 7.5mm x 55mm Multi-Directional Screw | In distribution |
| 501213 | Medium Standard Tip Hook for 5.5mm Rod | In distribution |
| 501655 | 6.5mm x 55mm Multi-Directional Screw | In distribution |
| 501760 | 7.5mm x 60mm Multi-Directional Screw | In distribution |
| 501770 | 7.5mm x 70mm Multi-Directional Screw | In distribution |
| 501215 | Wide Tip Hook for 5.5mm Rod, Small | In distribution |
| 501540 | 5.5mm x 40mm Multi-Directional Screw | In distribution |
| 501218 | Small Narrow Tip Hook for 5.5mm Rod | In distribution |
| 501545 | 5.5mm x 45mm Multi-Directional Screw | In distribution |
| 501765 | 7.5mm x 65mm Multi-Directional Screw | In distribution |
| 501725 | 7.5mm x 25mm Multi-Directional Screw | In distribution |
| 501212 | Small Standard tip Hook for 5.5mm Rod | In distribution |
| 501560 | 5.5mm x 60mm Multi-Directional Screw | In distribution |
| 501125 | 3/8 inch -16 Class 3, 3 degree/45 degree Buttress Thread | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Invictus | Alphatec Spine, Inc. | 5,422 |
| ReLine | Nuvasive, Inc. | 4,439 |
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 3,188 |
| Creo | Globus Medical, Inc. | 1,992 |
| Apex Spine System | Spinecraft LLC | 1,319 |
| LnK Spinal Fixation System | L&K Biomed Co., Ltd. | 1,271 |
| Perla ® TL | Spineart SA | 1,035 |
| Astra Spine System | Spinecraft LLC | 1,003 |
| LineSider | Highridge Medical, LLC | 948 |
| Apex-DL Spine System | Spinecraft LLC | 909 |
| Revere | Globus Medical, Inc. | 875 |
| AccelFix Spinal Fixation System | L&K Biomed Co., Ltd. | 841 |
Showing 12 of 536. All products under Appliance, Fixation, Spinal Interlaminal
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.