GSS Pedicle Screw System
"The GSS Pedicle Screw System is a top-loading multiple component, posterior spinal fixation system which consists of pedicle screws, rods, locking spacer, and a transverse (cross) linking…
“The GSS Pedicle Screw System is a top-loading multiple component, posterior spinal fixation system which consists of pedicle screws, rods, locking spacer, and a transverse (cross) linking mechanism. The GSS Pedicle Screw System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. The GSS Pedicle Screw System implant components are supplied non-sterile, single use and fabricated from titanium alloy (Ti-6AI-4V ELI) that conforms to ASTM F136. Various sizes of these implants are available. Specialized instruments are available for the application and removal of the GSS Pedicle Screw System. The GSS Pedicle Screw System is a pedicle screw system indicated for the treatment of severe Spondylolisthesis (Grade 3 and 4) of the L5-SI vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.”
Who Else Makes It
Concentrated in Jiangsu (7), Shanghai (2), Shandong (2). 4 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 |
| 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 |
| Suzhou Kangli Orthopaedics Instrument Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
| Changzhou Yonghua Medical Instruments Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 8 |
| Jiangsu Ideal Medical Science & Technology Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 7 |
Showing 12 of 13. All 13 manufacturers in China registered for Orthosis, Spondylolisthesis Spinal Fixation
Record
| Listed by | GS Medical Co., Ltd., South Korea |
|---|---|
| FDA product code | MNH |
| Device type | Orthosis, Spondylolisthesis Spinal Fixation |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Establishment | Manufacturer |
| 510(k) | K053573 |
| Record published | 2016-04-21 |
| Record revised | 2025-07-02 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, manufacturing date, serial number |
| Distribution end date | 2016-04-22 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| GS0103-7520 | In distribution | |
| GS0103-5530 | In distribution | |
| GS0150-0020 | In distribution | |
| GS0102-6545-A0 | In distribution | |
| GS0150-0500 | In distribution | |
| GS0150-0195 | In distribution | |
| GS0103-8555 | In distribution | |
| GS0103-7540 | In distribution | |
| GS0102-6560-A0 | In distribution | |
| GS0103-6545 | In distribution | |
| GS0103-8545 | In distribution | |
| GS0102-7570-A0 | In distribution | |
| GS0102-6550-A0 | In distribution | |
| GS0103-6555 | In distribution | |
| GS0103-7550 | In distribution | |
| GS0150-0010 | In distribution | |
| GS0103-5550 | In distribution | |
| GS0103-6525 | In distribution | |
| GS0103-7560 | In distribution | |
| GS0103-6535 | In distribution | |
| GS0103-8525 | In distribution | |
| GS0103-7530 | In distribution | |
| GS0103-5540 | In distribution | |
| GS0102-8545 | In distribution | |
| GS0102-8535 | In distribution | |
| GS0103-8535 | In distribution | |
| GS0102-8555 | In distribution | |
| GS0150-0500-M0 | In distribution | |
| GS0103-5560 | In distribution | |
| GS0103-5520 | In distribution | |
| GS0101-6540 | In distribution | |
| GS0101-4555 | Withdrawn | |
| GS0101-9560 | Withdrawn | |
| GS0101-9590 | Withdrawn | |
| GS0101-9530 | Withdrawn | |
| GS0101-9580 | Withdrawn | |
| GS0150-0165-M0 | Withdrawn | |
| GS0101-4545 | Withdrawn | |
| GS0101-9550 | Withdrawn | |
| GS0102-4540 | Withdrawn | |
| GS0101-9570 | Withdrawn | |
| GS0102-4560 | Withdrawn | |
| GS0101-4525 | Withdrawn | |
| GS0101-4535 | Withdrawn | |
| GS0102-4530 | Withdrawn | |
| GS0102-4550 | Withdrawn | |
| GS0101-9540 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 3,144 |
| Anax™ 5.5 Spinal System | CG MedTech Co., Ltd. | 2,177 |
| ReLine | Nuvasive, Inc. | 2,010 |
| Creo | Globus Medical, Inc. | 1,619 |
| Perfix™ Spinal System | CG MedTech Co., Ltd. | 1,476 |
| Apex Spine System | Spinecraft LLC | 1,193 |
| Olympic | Astura Medical | 1,173 |
| Arsenal | Alphatec Spine, Inc. | 1,001 |
| Revere | Globus Medical, Inc. | 997 |
| Astra Spine System | Spinecraft LLC | 798 |
| Apex-DL Spine System | Spinecraft LLC | 735 |
| Zenius Spinal System | Medyssey Co., Ltd. | 712 |
Showing 12 of 811. All products under Orthosis, Spondylolisthesis Spinal Fixation
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K053573 | 2006-03-08 |
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.