Neon™ Superior Spine System
neon screw, blue, self-drilling, cannulated, Ø 4.0 mm, length 48 mm
11manufacturers in China registered for this device type
83catalogue numbers in this listing
1510(k) clearance
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 | Ulrich Gmbh & Co. KG, Germany |
|---|---|
| FDA product code | KWP |
| Device type | Appliance, Fixation, Spinal Interlaminal |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3050 |
| Establishment | Contract manufacturer, Manufacturer, Exporter |
| 510(k) | K113346 |
| Record published | 2016-07-30 |
| Record revised | 2025-11-25 (version 7) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| Distribution end date | 2025-11-24 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CS 1408-120T | Withdrawn | |
| CS 1400-48T | Withdrawn | |
| CS 1409-17T | Withdrawn | |
| CS 1402-18T | Withdrawn | |
| CS 1400-34T | Withdrawn | |
| CS 1408-40T | Withdrawn | |
| CS 1401-18T | Withdrawn | |
| CS 1407T | Withdrawn | |
| CS 1401-24T | Withdrawn | |
| CS 1408-90T | Withdrawn | |
| CS 1400-36T | Withdrawn | |
| CS 1408-50T | Withdrawn | |
| CS 1408-45T | Withdrawn | |
| CS 1400-44T | Withdrawn | |
| CS 1402-12T | Withdrawn | |
| CS 1401-12T | Withdrawn | |
| CS 1404-14T | Withdrawn | |
| CS 1401-32T | Withdrawn | |
| CS 1410T | Withdrawn | |
| CS 1415-1T | Withdrawn | |
| CS 1401-28T | Withdrawn | |
| CS 1401-22T | Withdrawn | |
| CS 1401-14T | Withdrawn | |
| CS 1401-30T | Withdrawn | |
| CS 1400-40T | Withdrawn | |
| CS 1402-20T | Withdrawn | |
| CS 1403-40T | Withdrawn | |
| CS 1401-38T | Withdrawn | |
| CS 1415-5T | Withdrawn | |
| CS 1408-75T | Withdrawn | |
| CS 1400-50T | Withdrawn | |
| CS 1403-30T | Withdrawn | |
| CS 1404-8T | Withdrawn | |
| CS 1412-2T | Withdrawn | |
| CS 1401-10T | Withdrawn | |
| CS 1401-36T | Withdrawn | |
| CS 1409-01T | Withdrawn | |
| CS 1408-65T | Withdrawn | |
| CS 1418-03 | Withdrawn | |
| CS 1415-2T | Withdrawn | |
| CS 1408-160T | Withdrawn | |
| CS 1400-42T | Withdrawn | |
| CS 1403-50T | Withdrawn | |
| CS 1411-3T | Withdrawn | |
| CS 1404-16T | Withdrawn | |
| CS 1404-12T | Withdrawn | |
| CS 1400-46T | Withdrawn | |
| CS 1418-04 | Withdrawn | |
| CS 1408-95T | Withdrawn | |
| CS 1400-38T | Withdrawn | |
| CS 1419 | Withdrawn | |
| CS 1402-14T | Withdrawn | |
| CS 1408-35T | Withdrawn | |
| CS 1408-100T | Withdrawn | |
| CS 1408-20T | Withdrawn | |
| CS 1409-19T | Withdrawn | |
| CS 1404-18T | Withdrawn | |
| CS 1412-4T | Withdrawn | |
| CS 1401-34T | Withdrawn | |
| CS 1406T | Withdrawn | |
| CS 1409-15T | Withdrawn | |
| CS 1408-85T | Withdrawn | |
| CS 1408-140T | Withdrawn | |
| CS 1408-70T | Withdrawn | |
| CS 1401-20T | Withdrawn | |
| CS 1403-35T | Withdrawn | |
| CS 1411-4T | Withdrawn | |
| CS 1408-80T | Withdrawn | |
| CS 1418-02 | Withdrawn | |
| CS 1408-230T | Withdrawn | |
| CS 1408-60T | Withdrawn | |
| CS 1408-200T | Withdrawn | |
| CS 1402-16T | Withdrawn | |
| CS 1418-01 | Withdrawn | |
| CS 1401-26T | Withdrawn | |
| CS 1401-16T | Withdrawn | |
| CS 1408-30T | Withdrawn | |
| CS 1403-45T | Withdrawn | |
| CS 1408-25T | Withdrawn | |
| CS 1404-10T | Withdrawn | |
| CS 1408-55T | Withdrawn | |
| CS 1402-10T | Withdrawn | |
| CS 1415-3T | Withdrawn |
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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K113346 | 2012-02-28 |
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.