Neon³ CT Spinal Stabilization
Screw, cannulated, favored angle cranial, Ø 4.0 mm, length 38 mm
11manufacturers in China registered for this device type
65catalogue 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) | K150650 |
| Record published | 2016-09-22 |
| Record revised | 2026-05-27 (version 6) |
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, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CS 3925-03 | In distribution | |
| CS 3910-01-055 | In distribution | |
| CS 3918-06-17 | In distribution | |
| CS 3918-06-09 | In distribution | |
| CS 3902-35-16 | In distribution | |
| CS 3906-40-32 | In distribution | |
| CS 3907-45-50 | In distribution | |
| CS 3918-07-11 | In distribution | |
| CS 3905-40-36 | In distribution | |
| CS 3904-40-30 | In distribution | |
| CS 3918-07-09 | In distribution | |
| CS 3910-035 | In distribution | |
| CS 3910-080 | In distribution | |
| CS 3910-045 | In distribution | |
| CS 3901-01 | In distribution | |
| CS 3903-40-14 | In distribution | |
| CS 3906-40-24 | In distribution | |
| CS 3917-07 | In distribution | |
| CS 3902-35-26 | In distribution | |
| CS 3909-40-38 | In distribution | |
| CS 3909-40-46 | In distribution | |
| CS 3916-04 | In distribution | |
| CS 3907-55-50 | In distribution | |
| CS 3906-40-36 | In distribution | |
| CS 3910-01-110 | In distribution | |
| CS 3903-40-16 | In distribution | |
| CS 3903-40-18 | In distribution | |
| CS 3906-40-22 | In distribution | |
| CS 3906-40-30 | In distribution | |
| CS 3905-40-20 | In distribution | |
| CS 3909-40-50 | In distribution | |
| CS 3925-01 | In distribution | |
| CS 3911-240 | In distribution | |
| CS 3910-095 | In distribution | |
| CS 3902-35-18 | In distribution | |
| CS 3926-05 | In distribution | |
| CS 3903-40-10 | In distribution | |
| CS 3910-030 | In distribution | |
| CS 3910-01-040 | In distribution | |
| CS 3918-02-02 | In distribution | |
| CS 3907-45-35 | In distribution | |
| CS 3927-04 | In distribution | |
| CS 3910-070 | In distribution | |
| CS 3910-240 | In distribution | |
| CS 3910-01-060 | In distribution | |
| CS 3910-01-080 | In distribution | |
| CS 3932-07 | In distribution | |
| CS 3902-35-12 | In distribution | |
| CS 3907-45-40 | In distribution | |
| CS 3910-075 | In distribution | |
| CS 3910-200 | In distribution | |
| CS 3962-01 | In distribution | |
| CS 3907-55-55 | In distribution | |
| CS 3925-05 | In distribution | |
| CS 3905-40-30 | In distribution | |
| CS 3905-40-28 | In distribution | |
| CS 3928-04 | In distribution | |
| CS 3910-020 | In distribution | |
| CS 3907-45-45 | In distribution | |
| CS 3902-35-28 | In distribution | |
| CS 3929-05 | In distribution | |
| CS 3910-060 | In distribution | |
| CS 3907-45-30 | In distribution | |
| CS 3910-055 | In distribution | |
| CS 3912-200 | 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K113346 | 2012-02-28 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Ulrich Medical USA, Inc. | 510(k) number | 2019-12-31 | Class II | Process control | Due to a production error, the weld seam of the “Locking screw for crosslink, screw-to-screw” cannot reliably transmit the required torque of 3.5 Nm during installation. | 179 units | 2025-11-17 |
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.