Sterile Posterior Spinal Fixation System
The Sterile Posterior Spinal Fixation System uses pedicle screws, rods and interconnecting components to stabilize thoracolumbar spinal segments. The titanium-alloy implants form a…
The Sterile Posterior Spinal Fixation System uses pedicle screws, rods and interconnecting components to stabilize thoracolumbar spinal segments. The titanium-alloy implants form a posterior fixation construct with the associated surgical instruments.
RS8 LEGEND is the open-surgery set, while RS8 LONG is designed for minimally invasive placement. Each set includes screw, rod and accessory options in different dimensions.
Sterile Implant Configuration
The implants are supplied gamma-sterilized for single use. This sterile configuration differs from the earlier nonsterile posterior fixation system. The implants support stabilization of two or more spinal segments and are intended for removal once their stabilizing function is no longer needed.
Who Else Makes It
Concentrated in Jiangsu (6), Shanghai (3), Shandong (3). 6 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 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| 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 |
| Shanghai Reach Medical Instrument Co., Ltd. | Shanghai | Shanghai | Manufacturer | 30 |
| Changzhou Geasure Medical Apparatus AND Instruments Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 25 |
| Double Medical Technology Inc. | Xiamen | Fujian | Contract manufacturer | 14 |
Showing 12 of 15. All 15 manufacturers in China registered for Thoracolumbosacral Pedicle Screw System
Record
| Listed by | Shanghai Reach Medical Instrument Co., Ltd., China |
|---|---|
| FDA product code | NKB |
| Device type | Thoracolumbosacral Pedicle Screw System |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Establishment | Manufacturer |
| 510(k) | K221745 |
| Record published | 2026-05-22 |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Distribution end date | 2026-05-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SB21D-25545 | In distribution | |
| SB21D-26545 | In distribution | |
| SB211-35080 | In distribution | |
| SB211-34080 | In distribution | |
| SB21D-25030 | In distribution | |
| SB21D-26550 | In distribution | |
| SB211-34200 | In distribution | |
| SB211-35075 | In distribution | |
| SB211-35130 | In distribution | |
| SB211-32040 | In distribution | |
| SB211-32095 | In distribution | |
| SB211-35100 | In distribution | |
| SB211-32065 | In distribution | |
| SB22A-25545 | In distribution | |
| SB211-35135 | In distribution | |
| SB211-35145 | In distribution | |
| SB211-35095 | In distribution | |
| SB211-32055 | In distribution | |
| SB211-34095 | In distribution | |
| SB211-34115 | In distribution | |
| SB21D-25550 | In distribution | |
| SB22A-26555 | In distribution | |
| SB211-34150 | In distribution | |
| SB21D-26540 | In distribution | |
| SB21D-26535 | In distribution | |
| SB211-32060 | In distribution | |
| SB211-35090 | In distribution | |
| SB21D-26555 | In distribution | |
| SB21D-27545 | In distribution | |
| SB211-34105 | In distribution | |
| SB211-35070 | In distribution | |
| SB22A-26550 | In distribution | |
| SB22A-27550 | In distribution | |
| SB211-35150 | In distribution | |
| SB211-34090 | In distribution | |
| SB211-34140 | In distribution | |
| SB22A-26540 | In distribution | |
| SB21D-24535 | In distribution | |
| SB21D-25535 | In distribution | |
| SB211-34055 | In distribution | |
| SB22A-27555 | In distribution | |
| SB211-35050 | In distribution | |
| SB21D-27560 | In distribution | |
| SB211-32045 | In distribution | |
| SB211-35105 | In distribution | |
| SB21D-25540 | In distribution | |
| SB21D-27535 | In distribution | |
| SB211-32100 | In distribution | |
| SB22A-26560 | In distribution | |
| SB211-32080 | In distribution | |
| SB21D-27540 | In distribution | |
| SB211-34070 | In distribution | |
| SB211-32090 | In distribution | |
| SB21D-25045 | In distribution | |
| SB22A-27535 | In distribution | |
| SB211-34130 | In distribution | |
| SB22A-26545 | In distribution | |
| SB211-35085 | In distribution | |
| SB211-34085 | In distribution | |
| SB211-32075 | In distribution | |
| SB211-35040 | In distribution | |
| SB22A-25540 | In distribution | |
| SB211-34045 | In distribution | |
| SB211-35115 | In distribution | |
| SB211-34050 | In distribution | |
| SB21D-24530 | In distribution | |
| SB211-34120 | In distribution | |
| SB211-35120 | In distribution | |
| SB211-35065 | In distribution | |
| SB22A-26535 | In distribution | |
| SB21D-27550 | In distribution | |
| SB211-35045 | In distribution | |
| SB21D-25035 | In distribution | |
| SB21D-25040 | In distribution | |
| SB211-35140 | In distribution | |
| SB21D-26560 | In distribution | |
| SB211-34075 | In distribution | |
| SB22A-27540 | In distribution | |
| SB211-34065 | In distribution | |
| SB22A-27560 | In distribution | |
| SB211-32085 | In distribution | |
| SB211-34100 | In distribution | |
| SB211-34060 | In distribution | |
| SB22A-27545 | In distribution | |
| SB211-35125 | In distribution | |
| SB211-35110 | In distribution | |
| SB21D-26565 | In distribution | |
| SB211-34040 | In distribution | |
| SB211-35060 | In distribution | |
| SB211-35055 | In distribution | |
| SB211-32050 | In distribution | |
| SB21D-27555 | In distribution | |
| SB211-32070 | In distribution | |
| SB211-32120 | Withdrawn | |
| SB216-01095 | Withdrawn | |
| SB211-32130 | Withdrawn | |
| SB211-32140 | Withdrawn | |
| SB211-32300 | Withdrawn | |
| SB211-32110 | Withdrawn | |
| SB211-32105 | Withdrawn | |
| SB217-30370 | Withdrawn | |
| SB217-30380 | Withdrawn | |
| SB217-30360 | Withdrawn | |
| SB211-32200 | Withdrawn | |
| SB217-30340 | Withdrawn | |
| SB217-30350 | Withdrawn | |
| SB211-32150 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| The Jasper Spinal Fixation System | Gbs Commonwealth Co., Ltd. | 32,491 |
| Invictus | Alphatec Spine, Inc. | 4,722 |
| Vital Spinal Fixation System | Highridge Medical, LLC | 4,422 |
| Innoverse Spinal System | CG MedTech Co., Ltd. | 4,240 |
| 4CIS® Chiron Spinal Fixation System | Alpha AI Co., Ltd. | 3,787 |
| LnK Spinal Fixation System | L&K Biomed Co., Ltd. | 3,522 |
| Hedjet System | Medyssey Co., Ltd. | 3,438 |
| Anax™ 5.5 Spinal System | CG MedTech Co., Ltd. | 3,424 |
| Mega Plus MIS Spine System | BK Meditech Co., Ltd. | 3,396 |
| ReLine | Nuvasive, Inc. | 2,882 |
| Nex-D2 | Next Orthosurgical | 2,765 |
| AnyPlus Spinal Fixation System | GS Medical Co., Ltd. | 2,386 |
Showing 12 of 1,490. All products under Thoracolumbosacral Pedicle Screw System
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K221745 | 2022-08-31 |
| K201737 | 2021-06-21 |
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.