Neon³ CT Spinal Stabilization
Screw, cannulated, favored angle cranial, Ø 4.0 mm, length 48 mm
4manufacturers in China registered for this device type
77catalogue numbers in this listing
2510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (1), Shandong (1), Fujian (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| 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 | NKG |
| Device type | Posterior Cervical Screw System |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3075 |
| Establishment | Contract manufacturer, Manufacturer, Exporter |
| 510(k) | K150650 |
| Record published | 2016-09-22 |
| Record revised | 2025-08-06 (version 6) |
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 | 2024-08-28 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CS 3904-40-40 | In distribution | |
| CS 3904-40-36 | In distribution | |
| CS 3917-06 | In distribution | |
| CS 3907-45-25 | In distribution | |
| CS 3906-40-26 | In distribution | |
| CS 3909-40-48 | In distribution | |
| CS 3909-40-42 | In distribution | |
| CS 3909-40-40 | In distribution | |
| CS 3925-04 | In distribution | |
| CS 3916-02 | In distribution | |
| CS 3907-55-30 | In distribution | |
| CS 3918-02-03 | In distribution | |
| CS 3910-065 | In distribution | |
| CS 3906-40-20 | In distribution | |
| CS 3904-40-28 | In distribution | |
| CS 3906-40-34 | In distribution | |
| CS 3918-06-07 | In distribution | |
| CS 3917-05 | In distribution | |
| CS 3902-35-24 | In distribution | |
| CS 3918-07-07 | In distribution | |
| CS 3902-35-22 | In distribution | |
| CS 3909-40-36 | In distribution | |
| CS 3904-40-26 | In distribution | |
| CS 3910-040 | In distribution | |
| CS 3925-02 | In distribution | |
| CS 3904-40-38 | In distribution | |
| CS 3910-140 | In distribution | |
| CS 3918-07-20 | In distribution | |
| CS 3910-01-045 | In distribution | |
| CS 3910-100 | In distribution | |
| CS 3906-40-28 | In distribution | |
| CS 3910-160 | In distribution | |
| CS 3903-40-12 | In distribution | |
| CS 3910-01-030 | In distribution | |
| CS 3926-04 | In distribution | |
| CS 3916-03 | In distribution | |
| CS 3918-06-14 | In distribution | |
| CS 3910-01-050 | In distribution | |
| CS 3909-40-34 | In distribution | |
| CS 3929-06 | In distribution | |
| CS 3907-55-45 | In distribution | |
| CS 3907-55-25 | In distribution | |
| CS 3902-35-20 | In distribution | |
| CS 3910-025 | In distribution | |
| CS 3919-02 | In distribution | |
| CS 3905-40-22 | In distribution | |
| CS 3910-01-120 | In distribution | |
| CS 3910-01-025 | In distribution | |
| CS 3918-01 | In distribution | |
| CS 3918-06-20 | In distribution | |
| CS 3910-01-100 | In distribution | |
| CS 3902-35-14 | In distribution | |
| CS 3918-06-11 | In distribution | |
| CS 3905-40-32 | In distribution | |
| CS 3903-40-20 | In distribution | |
| CS 3910-01-035 | In distribution | |
| CS 3902-35-10 | In distribution | |
| CS 3905-40-34 | In distribution | |
| CS 3910-01-090 | In distribution | |
| CS 3916-01 | In distribution | |
| CS 3910-090 | In distribution | |
| CS 3928-05 | In distribution | |
| CS 3904-40-34 | In distribution | |
| CS 3918-07-14 | In distribution | |
| CS 3918-07-17 | In distribution | |
| CS 3909-40-44 | In distribution | |
| CS 3907-55-35 | In distribution | |
| CS 3919-01 | In distribution | |
| CS 3910-085 | In distribution | |
| CS 3905-40-24 | In distribution | |
| CS 3910-120 | In distribution | |
| CS 3910-01-070 | In distribution | |
| CS 3910-050 | In distribution | |
| CS 3904-40-32 | In distribution | |
| CS 3905-40-26 | In distribution | |
| CS 3907-55-40 | In distribution | |
| CS 3902-35-30 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Bridalveil | Astura Medical | 1,718 |
| Proficient™ Posterior Cervical Spine System | Spine Wave, Inc. | 1,590 |
| Invictus | Alphatec Spine, Inc. | 1,538 |
| Paeon Posterior Cervical Fixation System | Aegis Spine | 1,408 |
| ReLine | Nuvasive, Inc. | 1,072 |
| PathLoc-C Posterior Cervical Fixation System | L&K Biomed Co., Ltd. | 706 |
| Cosy | Signus Medizintechnik Gmbh | 550 |
| Yukon OCT Spinal System | VB Spine LLC | 451 |
| Astra-OCT Spine System | Spinecraft LLC | 440 |
| Symphony | Medos International Sàrl | 389 |
| Medyssey Poseidon OCT Spinal Fixation System | Medyssey Co., Ltd. | 387 |
| Infinity™ Occipitocervical Upper Thoracic System | Medtronic Sofamor Danek, Inc. | 375 |
Showing 12 of 336. All products under Posterior Cervical Screw System
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K161032 | 2016-12-22 |
| K150650 | 2015-09-24 |
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.