UCR
ROD, 5.5 X 110MM. The UCR system contains polyaxial screws of varying reduction height, rods, caps, set screws, crosslinks, crossbars and hooks. Implants are offered in a variety of lengths…
ROD, 5.5 X 110MM. The UCR system contains polyaxial screws of varying reduction height, rods, caps, set screws, crosslinks, crossbars and hooks. Implants are offered in a variety of lengths to accommodate variations in patient anatomy and are manufactured from Titanium 6Aluminum-4Vanadium ELI, with the exception of the Malibu and NewPort Cobalt 28Chromium-6Molybdenum component in the polyaxial screws and the Cobalt35Nickel-20Chromium-10Molybdenum alloy with lower inclusion counts used for some rods and wires.
Who Else Makes It
Concentrated in Jiangsu (7), Shanghai (2), Shandong (2). 4 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 |
| 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 |
| Suzhou Kangli Orthopaedics Instrument Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
| Changzhou Yonghua Medical Instruments Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 8 |
| Jiangsu Ideal Medical Science & Technology Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 7 |
Showing 12 of 13. All 13 manufacturers in China registered for Orthosis, Spondylolisthesis Spinal Fixation
Record
| Listed by | Seaspine Orthopedics Corporation, United States |
|---|---|
| FDA product code | MNH |
| Device type | Orthosis, Spondylolisthesis Spinal Fixation |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K043232 |
| Record published | 2015-09-24 |
| Record revised | 2025-10-24 (version 8) |
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 |
|---|---|---|
| 10-1004 | 5.5mm X 40mm | In distribution |
| 10-6035 | 6.0 x 35 mm | In distribution |
| 10-5540 | 5.5 x 40 mm | In distribution |
| 10-5555 | 5.5 x 55 mm | In distribution |
| 11-8030 | 8.0 x 30mm | In distribution |
| 11-1045 | 6.35 x 450MM | In distribution |
| 14-9065 | 6.5mm | In distribution |
| 10-6045 | 6.0 x 45 mm | In distribution |
| 10-4725 | 4.75 x 25 mm | In distribution |
| 11-2037 | 5.5mm | In distribution |
| 11-5525 | 5.5 x 25 mm | In distribution |
| 11-1010 | 6.35 x 100MM | In distribution |
| 10-0016 | 5.5/6.75mm | In distribution |
| 11-0026 | 6.35mm | In distribution |
| 11-4725 | 4.75 x 25 mm | In distribution |
| 11-8050 | 8.0 x 50mm | In distribution |
| 11-8060 | 8.0 x 60mm | In distribution |
| 11-6755 | 6.75 x 55 mm | In distribution |
| 10-0018 | 8MM | In distribution |
| 10-6730 | 6.75 x 30 mm | In distribution |
| 11-6040 | 6.0 x 40 mm | In distribution |
| 11-1011 | 6.35 x 110MM | In distribution |
| 10-0026 | 5.5/6.75 | In distribution |
| 11-5550 | 5.5 x 50 mm | In distribution |
| 11-6025 | 6.0 x 25 mm | In distribution |
| 10-3150 | 5.5 x 150mm | In distribution |
| 11-6750 | 6.75 x 50 mm | In distribution |
| 11-4730 | 4.75 x 30 mm | In distribution |
| 10-1008 | 5.5mm X 80mm | In distribution |
| 14-9050 | 9.0 X 5.0 MM | In distribution |
| 10-8030 | 8.0 x 30 mm | In distribution |
| 10-1011 | 5.5mm X 110mm Rod | In distribution |
| 11-3057 | 6.35mm | In distribution |
| 11-6745 | 6.75 x 45 mm | In distribution |
| 10-4745 | 4.75 x 45 mm | In distribution |
| 11-5540 | 5.5 x 40 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 3,144 |
| Anax™ 5.5 Spinal System | CG MedTech Co., Ltd. | 2,177 |
| ReLine | Nuvasive, Inc. | 2,010 |
| Creo | Globus Medical, Inc. | 1,619 |
| Perfix™ Spinal System | CG MedTech Co., Ltd. | 1,476 |
| Apex Spine System | Spinecraft LLC | 1,193 |
| Olympic | Astura Medical | 1,173 |
| Arsenal | Alphatec Spine, Inc. | 1,001 |
| Revere | Globus Medical, Inc. | 997 |
| Astra Spine System | Spinecraft LLC | 798 |
| Apex-DL Spine System | Spinecraft LLC | 735 |
| Zenius Spinal System | Medyssey Co., Ltd. | 712 |
Showing 12 of 811. All products under Orthosis, Spondylolisthesis Spinal Fixation
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 |
|---|---|---|---|---|---|---|---|
| Seaspine, Inc. | 510(k) number | 2014-05-21 | Class II | Under Investigation by firm | Integra has identified through an investigation of complaints that there may be the potential for the tip of a single lot number of the UCR 3mm Hex, Large Axial Driver, 91-1123 to twist or become rounded during use. | 7 | 2014-12-15 |
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.