Union MAX
The variable screw in the uNion MAX range is a titanium alloy component used with anterior cervical plates. The construct provides mechanical support across treated cervical levels until…
The variable screw in the uNion MAX range is a titanium alloy component used with anterior cervical plates. The construct provides mechanical support across treated cervical levels until fusion. Screw options include 4.0 and 4.5 mm diameters with self-drilling, self-tapping or combined tip designs.
The system is intended for anterior fixation from C2 to T1 as an adjunct to fusion. Its plates span one to four levels and incorporate a pivoting locking mechanism that blocks screw backout. Fixed and variable screw configurations are available.
Listed Item
Screw, Ø4.0 x 18mm, Self-Drilling/Self-Tapping Light Blue, Variable
Indications and Supply
System indications include degenerative disc disease, spondylolisthesis, fractures or dislocations, tumors, spinal stenosis, deformity, pseudoarthrosis and failed previous fusion. Components are manufactured from Ti-6Al-4V ELI titanium alloy and are supplied nonsterile. The screw is one element of the assembled plate fixation construct.
Who Else Makes It
Concentrated in Jiangsu (5), Shanghai (3), Zhejiang (2). 8 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| 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 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| 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 |
| Double Medical Technology Inc. | Xiamen | Fujian | Contract manufacturer | 14 |
Showing 12 of 14. All 14 manufacturers in China registered for Appliance, Fixation, Spinal Intervertebral Body
Record
| Listed by | Ulrich Medical USA, Inc., United States |
|---|---|
| FDA product code | KWQ |
| Device type | Appliance, Fixation, Spinal Intervertebral Body |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3060 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K240515 |
| Record published | 2024-08-05 |
| Record revised | 2025-11-20 (version 2) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| UU201-01-0009 | In distribution | |
| UU201-01-0008 | In distribution | |
| UU202-05-0101 | In distribution | |
| UU202-03-0005 | In distribution | |
| UU201-22-4016 | In distribution | |
| UU202-03-03 | In distribution | |
| UU201-03-0060 | In distribution | |
| UU201-42-4522 | In distribution | |
| UU202-06-0007 | In distribution | |
| UU201-41-4024 | In distribution | |
| UU201-42-4514 | In distribution | |
| UU201-01-0025 | In distribution | |
| UU201-21-4522 | In distribution | |
| UU201-42-4516 | In distribution | |
| UU201-42-4012 | In distribution | |
| UU201-02-0043 | In distribution | |
| UU202-03-0010 | In distribution | |
| UU202-10-22 | In distribution | |
| UU202-06-0011 | In distribution | |
| UU201-01-0014 | In distribution | |
| UU201-04-0076 | In distribution | |
| UU202-03-0011 | In distribution | |
| UU201-02-0046 | In distribution | |
| UU201-22-4512 | In distribution | |
| UU201-04-0064 | In distribution | |
| UU202-06-0009 | In distribution | |
| UU201-03-0063 | In distribution | |
| UU201-22-4022 | In distribution | |
| UU201-42-4022 | In distribution | |
| UU201-02-0022 | In distribution | |
| UU201-42-4014 | In distribution | |
| UU201-03-0051 | In distribution | |
| UU201-01-0011 | In distribution | |
| UU201-21-4018 | In distribution | |
| UU201-42-4018 | In distribution | |
| UU202-10-10 | In distribution | |
| UU201-01-0019 | In distribution | |
| UU201-42-4020 | In distribution | |
| UU201-21-4520 | In distribution | |
| UU202-05-0100 | In distribution | |
| UU201-04-0072 | In distribution | |
| UU201-21-4512 | In distribution | |
| UU201-42-4520 | In distribution | |
| UU201-21-4516 | In distribution | |
| UU201-41-4016 | In distribution | |
| UU203-00-02 | In distribution | |
| UU202-06-0010 | In distribution | |
| UU201-02-0040 | In distribution | |
| UU202-10-24 | In distribution | |
| UU201-21-4022 | In distribution | |
| UU201-41-4018 | In distribution | |
| UU203-00-00 | In distribution | |
| UU201-42-4518 | In distribution | |
| UU201-41-4014 | In distribution | |
| UU201-22-4018 | In distribution | |
| UU201-41-4514 | In distribution | |
| UU201-21-4518 | In distribution | |
| UU201-01-0010 | In distribution | |
| UU201-22-4020 | In distribution | |
| UU202-10-14 | In distribution | |
| UU201-03-0054 | In distribution | |
| UU202-12-04 | In distribution | |
| UU201-02-0034 | In distribution | |
| UU201-02-0028 | In distribution | |
| UU202-03-0006 | In distribution | |
| UU201-01-0021 | In distribution | |
| UU201-02-0026 | In distribution | |
| UU201-41-4524 | In distribution | |
| UU202-18-30 | In distribution | |
| UU201-21-4524 | In distribution | |
| UU201-03-0039 | In distribution | |
| UU201-41-4520 | In distribution | |
| UU202-18-15 | In distribution | |
| UU201-02-0037 | In distribution | |
| UU201-04-0060 | In distribution | |
| UU201-22-4012 | In distribution | |
| UU202-05-0102 | In distribution | |
| UU201-03-0045 | In distribution | |
| UU201-41-4518 | In distribution | |
| UU201-41-4012 | In distribution | |
| UU201-22-4014 | In distribution | |
| UU201-01-0012 | In distribution | |
| UU202-03-01 | In distribution | |
| UU201-42-4524 | In distribution | |
| UU201-02-0020 | In distribution | |
| UU201-41-4516 | In distribution | |
| UU202-10-20 | In distribution | |
| UU202-10-12 | In distribution | |
| UU201-42-4024 | In distribution | |
| UU202-03-02 | In distribution | |
| UU201-03-0066 | In distribution | |
| UU201-22-4516 | In distribution | |
| UU201-21-4020 | In distribution | |
| UU202-06-0012 | In distribution | |
| UU201-41-4522 | In distribution | |
| UU201-22-4514 | In distribution | |
| UU201-04-0068 | In distribution | |
| UU201-03-0057 | In distribution | |
| UU201-01-0023 | In distribution | |
| UU202-10-16 | In distribution | |
| UU201-02-0024 | In distribution | |
| UU201-42-4016 | In distribution | |
| UU000-00-01 | In distribution | |
| UU202-03-0004 | In distribution | |
| UU201-42-4512 | In distribution | |
| UU201-22-4024 | In distribution | |
| UU201-03-0042 | In distribution | |
| UU201-21-4514 | In distribution | |
| UU201-03-0069 | In distribution | |
| UU201-02-0030 | In distribution | |
| UU202-10-18 | In distribution | |
| UU201-01-0015 | In distribution | |
| UU201-04-0084 | In distribution | |
| UU201-22-4522 | In distribution | |
| UU202-06-0005 | In distribution | |
| UU201-21-4014 | In distribution | |
| UU201-21-4024 | In distribution | |
| UU201-03-0048 | In distribution | |
| UU201-04-0080 | In distribution | |
| UU201-22-4520 | In distribution | |
| UU201-41-4020 | In distribution | |
| UU201-22-4524 | In distribution | |
| UU202-06-0006 | In distribution | |
| UU201-21-4016 | In distribution | |
| UU202-00-0000 | In distribution | |
| UU201-21-4012 | In distribution | |
| UU201-41-4022 | In distribution | |
| UU202-12-02 | In distribution | |
| UU201-01-0013 | In distribution | |
| UU201-03-0036 | In distribution | |
| UU201-02-0032 | In distribution | |
| UU201-22-4518 | In distribution | |
| UU202-06-0008 | In distribution | |
| UU202-03-0003 | In distribution | |
| UU201-01-0017 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| ReLine | Nuvasive, Inc. | 2,998 |
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 2,568 |
| Creo | Globus Medical, Inc. | 1,765 |
| AccelFix Spinal Fixation System | L&K Biomed Co., Ltd. | 1,755 |
| Ozark Cervical Plate System | VB Spine LLC | 1,460 |
| Sirion | Astura Medical | 1,246 |
| Apex Spine System | Spinecraft LLC | 1,187 |
| AnyPlus Spinal Fixation System | GS Medical Co., Ltd. | 986 |
| Astra Spine System | Spinecraft LLC | 970 |
| Zavation | Zavation | 966 |
| ACP | Nuvasive, Inc. | 918 |
| Polaris™ 5.5 Spinal System | Biomet Spine | 877 |
Showing 12 of 855. All products under Appliance, Fixation, Spinal Intervertebral Body
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K240515 | 2024-03-18 |
| K150666 | 2015-06-22 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2017-03-07 | Class II | Use error | Surgical technique was revised to prevent static plate screws blocking mechanisms from disassociating. | 4,854 plates | 2017-11-30 |
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.