Neo Medical Pedicle Screw Kit
NEO Medical Pedicle Screw Kit is part of a spinal fixation system of titanium-alloy screws and connecting rods. The screws are cannulated, fenestrated, self-tapping and double-threaded,…
NEO Medical Pedicle Screw Kit is part of a spinal fixation system of titanium-alloy screws and connecting rods. The screws are cannulated, fenestrated, self-tapping and double-threaded, with colour coding to identify diameter.
The screw and rod construct stabilizes the treated spinal segments. Rods have a 5.5 mm diameter and are available straight, prebent or in a special bent configuration for the L5-S1 region.
Listed Item
Pedicle screw kit 2x(Ø6.0 x 35mm)
Sterile Components and Instruments
Implants and the associated disposable instruments are supplied gamma-sterilized for single use. Screw options range from 5 to 7 mm in diameter and 35 to 55 mm long, while rod lengths vary by configuration. A clip can lock the polyaxial screw into monoaxial mode.
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 | NEO Medical Inc., United States |
|---|---|
| FDA product code | NKB |
| Device type | Thoracolumbosacral Pedicle Screw System |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K171582 |
| Record published | 2017-10-27 |
| Record revised | 2024-09-11 (version 5) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 5 to 35 °C |
| Sizes | Length 30 to 300 mm; outer diameter 5 to 10 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| RD-00-40-ST | Length 40 mm | In distribution |
| RD-01-60-ST | Length 160 mm | In distribution |
| RD-00-30-SB | Length 30 mm | In distribution |
| RD-00-90-ST | Length 90 mm | In distribution |
| SC-60-35-PE | Outer Diameter 6 mm | In distribution |
| RD-00-30-ST | Length 30 mm | In distribution |
| RD-00-80-ST | Length 80 mm | In distribution |
| RD-01-00-PB | Length 100 mm | In distribution |
| SC-10-80-IL | Outer Diameter 10.0 mm | In distribution |
| SC-50-35-PE | Outer Diameter 5 mm | In distribution |
| SC-60-40-PE | Outer Diameter 6 mm | In distribution |
| SC-50-50-PE | Outer Diameter 5 mm | In distribution |
| SC-60-50-PE | Outer Diameter 6 mm | In distribution |
| CO-01-50-IL | Length 150 mm | In distribution |
| RD-00-50-PB | Length 50 mm | In distribution |
| SC-10-10-IL | Outer Diameter 10.0 mm | In distribution |
| RD-00-70-ST | Length 70 mm | In distribution |
| RD-01-30-ST | Length 130 mm | In distribution |
| SC-10-70-IL | Outer Diameter 10.0 mm | In distribution |
| SC-60-45-PE | Outer Diameter 6 mm | In distribution |
| RD-03-00-ST | Length 300 mm | In distribution |
| RD-00-70-PB | Length 70 mm | In distribution |
| CO-00-00-EE | In distribution | |
| RD-00-90-PB | Length 90 mm | In distribution |
| SC-70-55-PE | Outer Diameter 7 mm | In distribution |
| SC-70-50-PE | Outer Diameter 7 mm | In distribution |
| RD-00-50-ST | Length 50 mm | In distribution |
| RD-00-80-PB | Length 80 mm | In distribution |
| SC-10-90-IL | Outer Diameter 10.0 mm | In distribution |
| RD-00-40-SB | Length 40 mm | In distribution |
| SC-70-45-PE | Outer Diameter 7 mm | In distribution |
| RD-01-00-ST | Length 100 mm | In distribution |
| RD-00-35-ST | Length 35 mm | In distribution |
| SC-50-40-PE | Length 40 mm | In distribution |
| SC-50-45-PE | Outer Diameter 5 mm | In distribution |
| RD-00-60-ST | Length 60 mm | In distribution |
| SC-70-35-PE | Outer Diameter 7 mm | In distribution |
| SC-60-55-PE | Outer Diameter 6 mm | In distribution |
| RD-02-00-ST | Length 200 mm | In distribution |
| SC-70-40-PE | Outer Diameter 7 mm | In distribution |
| RD-00-60-PB | Length 60 mm | In distribution |
| RD-00-40-PB | Length 40 mm | In distribution |
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 |
|---|---|
| K243693 | 2024-12-23 |
| K171582 | 2017-09-12 |
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.