GSO PCT Spinal System
Smooth Shank Multi-Axial Screw
11manufacturers in China registered for this device type
94catalogue 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 | 2015-08-31 |
| Record revised | 2025-07-14 (version 7) |
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 |
|---|---|---|
| 506644 | 3.5mm x 44mm Smooth Shank Multi-Axial Screw | In distribution |
| 506648 | 3.5mm x 48mm Smooth Shank Multi-Axial Screw | In distribution |
| 506280 | 6.0mm PCT Hook | In distribution |
| 506102 | 3.5mm x 80mm Spinal Rod | In distribution |
| 506422 | 4.0mm x 22mm Multi-Axial Screw | In distribution |
| 506106 | 3.5mm x 160mm Spinal Rod | In distribution |
| 506630 | 3.5mm x 30mm Smooth Shank Multi-Axial Screw | In distribution |
| 506420 | 4.0mm x 20mm Multi-Axial Screw | In distribution |
| 506632 | 3.5mm x 32mm Smooth Shank Multi-Axial Screw | In distribution |
| 506640 | 3.5mm x 40mm Smooth Shank Multi-Axial Screw | In distribution |
| 506640 | 3.5mm x 40mm Smooth Shank Multi-Axial Screw | In distribution |
| 506636 | 3.5mm x 36mm Smooth Shank Multi-Axial Screw | In distribution |
| 506532 | 4.5mm x 32mm Multi-Axial Screw | In distribution |
| 506650 | 3.5mm x 50mm Smooth Shank Multi-Axial Screw | In distribution |
| 506100 | 3.5mm x 40mm Spinal Rod | In distribution |
| 506428 | 4.0mm x 28mm Multi-Axial Screw | In distribution |
| 506270 | 4.5mm Hook for 3.5mm Rod System | In distribution |
| 506628 | 3.5mm x 28mm Smooth Shank Multi-Axial Screw | In distribution |
| 506524 | 4.5mm x 24mm Multi-Axial Screw | In distribution |
| 506270 | 4.5mm PCT Hook | In distribution |
| 506638 | 3.5mm x 38mm Smooth Shank Multi-Axial Screw | In distribution |
| 506316 | 3.5mm x 16mm Mulit-Axial Screw | In distribution |
| 506638 | 3.5mm x 38mm Smooth Shank Multi-Axial Screw | In distribution |
| 506532 | 4.5mm x 32mm Multi-Axial Screw | In distribution |
| 506412 | 4.0mm x 12mm Multi-Axial Screw | In distribution |
| 506630 | 3.5mm x 30mm Smooth Shank Multi-Axial Screw | In distribution |
| 506418 | 4.0mm x 18mm Multi-Axial Screw | In distribution |
| 506322 | 3.5mm x 22mm Mulit-Axial Screw | In distribution |
| 506312 | 3.5mm x 12mm Multi-Axial Screw | In distribution |
| 506310 | 3.5mm x 10mm Multi-Axial Screw | In distribution |
| 506120 | 1/4 inch -28 Class 3, 7 degree/45 degree Buttress Thread | In distribution |
| 506412 | 4.0mm x 12mm Multi-Axial Screw | In distribution |
| 506422 | 4.0mm x 22mm Multi-Axial Screw | In distribution |
| 506650 | 3.5mm x 50mm Smooth Shank Multi-Axial Screw | In distribution |
| 506528 | 4.5mm x 28mm Multi-Axial Screw | In distribution |
| 506110 | 3.5mm x 240mm Spinal Rod | In distribution |
| 506424 | 4.0mm x 24mm Multi-Axial Screw | In distribution |
| 506626 | 3.5mm x 26mm Smooth Shank Multi-Axial Screw | In distribution |
| 506420 | 4.0mm x 20mm Multi-Axial Screw | In distribution |
| 506410 | 4.0mm x 10mm Multi-Axial Screw | In distribution |
| 506280 | 6.0mm Hook for 3.5mm Rod System | In distribution |
| 506322 | 3.5mm x 22mm Mulit-Axial Screw | In distribution |
| 506426 | 4.0mm x 26mm Multi-Axial Screw | In distribution |
| 506108 | 3.5mm x 200mm Spinal Rod | In distribution |
| 506416 | 4.0mm x 16mm Multi-Axial Screw | In distribution |
| 506642 | 3.5mm x 42mm Smooth Shank Multi-Axial Screw | In distribution |
| 506106 | 3.5mm x 160mm Spinal Rod | In distribution |
| 506620 | 3.5mm x 20mm Smooth Shank Multi-Axial Screw | In distribution |
| 506108 | 3.5mm x 200mm Spinal Rod | In distribution |
| 506520 | 4.5mm x 20mm Multi-Axial Screw | In distribution |
| 506414 | 4.0mm x 14mm Multi-Axial Screw | In distribution |
| 506416 | 4.0mm x 16mm Multi-Axial Screw | In distribution |
| 506316 | 3.5mm x 16mm Mulit-Axial Screw | In distribution |
| 506219 | Adjustable Cross-Connector | In distribution |
| 506100 | 3.5mm x 40mm Spinal Rod | In distribution |
| 506632 | 3.5mm x 32mm Smooth Shank Multi-Axial Screw | In distribution |
| 506104 | 3.5mm x 120mm Spinal Rod | In distribution |
| 506634 | 3.5mm x 34mm Smooth Shank Multi-Axial Screw | In distribution |
| 506524 | 4.5mm x 24mm Multi-Axial Screw | In distribution |
| 506318 | 3.5mm x 18mm Mulit-Axial Screw | In distribution |
| 506644 | 3.5mm x 44mm Smooth Shank Multi-Axial Screw | In distribution |
| 506314 | 3.5mm x 14mm Multi-Axial Screw | In distribution |
| 506310 | 3.5mm x 10mm Multi-Axial Screw | In distribution |
| 506312 | 3.5mm x 12mm Multi-Axial Screw | In distribution |
| 506628 | 3.5mm x 28mm Smooth Shank Multi-Axial Screw | In distribution |
| 506646 | 3.5mm x 46mm Smooth Shank Multi-Axial Screw | In distribution |
| 506418 | 4.0mm x 18mm Multi-Axial Screw | In distribution |
| 506646 | 3.5mm x 46mm Smooth Shank Multi-Axial Screw | In distribution |
| 506110 | 3.5mm x 240mm Spinal Rod | In distribution |
| 506314 | 3.5mm x 14mm Multi-Axial Screw | In distribution |
| 506648 | 3.5mm x 48mm Smooth Shank Multi-Axial Screw | In distribution |
| 506320 | 3.5mm x 20mm Mulit-Axial Screw | In distribution |
| 506528 | 4.5mm x 28mm Multi-Axial Screw | In distribution |
| 506622 | 3.5mm x 22mm Smooth Shank Multi-Axial Screw | In distribution |
| 506634 | 3.5mm x 34mm Smooth Shank Multi-Axial Screw | In distribution |
| 506102 | 3.5mm x 80mm Spinal Rod | In distribution |
| 506424 | 4.0mm x 24mm Multi-Axial Screw | In distribution |
| 506620 | 3.5mm x 20mm Smooth Shank Multi-Axial Screw | In distribution |
| 506624 | 3.5mm x 24mm Smooth Shank Multi-Axial Screw | In distribution |
| 506520 | 4.5mm x 20mm Multi-Axial Screw | In distribution |
| 506414 | 4.0mm x 14mm Multi-Axial Screw | In distribution |
| 506642 | 3.5mm x 42mm Smooth Shank Multi-Axial Screw | In distribution |
| 506219 | Adjustable Cross-Connector | In distribution |
| 506428 | 4.0mm x 28mm Multi-Axial Screw | In distribution |
| 506426 | 4.0mm x 26mm Multi-Axial Screw | In distribution |
| 506318 | 3.5mm x 18mm Mulit-Axial Screw | In distribution |
| 506622 | 3.5mm x 22mm Smooth Shank Multi-Axial Screw | In distribution |
| 506320 | 3.5mm x 20mm Mulit-Axial Screw | In distribution |
| 506626 | 3.5mm x 26mm Smooth Shank Multi-Axial Screw | In distribution |
| 506104 | 3.5mm x 120mm Spinal Rod | In distribution |
| 506636 | 3.5mm x 36mm Smooth Shank Multi-Axial Screw | In distribution |
| 506410 | 4.0mm x 10mm Multi-Axial Screw | In distribution |
| 506624 | 3.5mm x 24mm Smooth Shank Multi-Axial Screw | In distribution |
| 506120 | 1/4 inch -28 Class 3, 7 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.