U.l.i.s.™
U.L.I.S.™ multi-axial reduction screw 4.5mm x 40mm
14manufacturers in China registered for this device type
101catalogue numbers in this listing
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 | Spinevision SAS, France |
|---|---|
| FDA product code | KWQ |
| Device type | Appliance, Fixation, Spinal Intervertebral Body |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3060 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K112607 |
| Record published | 2016-05-18 |
| Record revised | 2025-01-15 (version 4) |
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, serial number |
| Sizes | Outer diameter 4.5 to 10.5 mm; length 25 to 90 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IS2-MR830T | Length 30 mm | In distribution |
| IS1-M645T | Diameter: 6.5 Milliimeters Length: 45 Milliimeters | In distribution |
| IS2-MR625T | Length 25 mm | In distribution |
| IS2-MR660T | Outer Diameter 6.5 mm | In distribution |
| IS2-MR890T | Length 90 mm | In distribution |
| IS2-MR1055T | Length 55 mm | In distribution |
| IS1-M650T | Diameter: 6.5 Milliimeters Length: 50 Milliimeters | In distribution |
| IS2-S760T | Diameter: 7.5 Milliimeters Length: 60 Milliimeters | In distribution |
| IS2-MR450T | Length 50 mm | In distribution |
| IS2-MR1090T | Length 90 mm | In distribution |
| IS1-TRAY112 | In distribution | |
| IS2-MR560T | Length 60 mm | In distribution |
| IS2-S870T | Diameter: 8.5 Milliimeters Length: 70 Milliimeters | In distribution |
| IS2-MR835T | Length 35 mm | In distribution |
| IS2-M540T | Diameter: 5.5 Milliimeters Length: 40 Milliimeters | In distribution |
| IS2-MR760T | Length 60 mm | In distribution |
| IS2-M1055T | Diameter: 10.5 Milliimeters Length: 55 Milliimeters | In distribution |
| IS2-MR1085T | Length 85 mm | In distribution |
| IS2-MR550T | Length 50 mm | In distribution |
| IS2-MR1035T | Length 35 mm | In distribution |
| IS2-M735T | Diameter: 7.5 Milliimeters Length: 35 Milliimeters | In distribution |
| IS2-S875T | Diameter: 8.5 Milliimeters Length: 75 Milliimeters | In distribution |
| IS1-M535T | Diameter: 5.5 Milliimeters Length: 35 Milliimeters | In distribution |
| IS2-M1075T | Diameter: 10.5 Milliimeters Length: 75 Milliimeters | In distribution |
| IS2-MR535T | Length 35 mm | In distribution |
| IS1-ID | In distribution | |
| IS2-MR430T | Length 30 mm | In distribution |
| IS2-MR440T | Length 40 mm | In distribution |
| IS2-MR745T | Length 45 mm | In distribution |
| IS2-S635T | Diameter: 6.5 Milliimeters Length: 35 Milliimeters | In distribution |
| IS2-S1035T | Diameter: 10.5 Milliimeters Length: 35 Milliimeters | In distribution |
| U1 – R605HC | Diameter:6.0 Milliimeters Length: 50 Milliimeters | In distribution |
| IS1-M745T | Diameter: 7.5 Milliimeters Length: 45 Milliimeters | In distribution |
| IS2-MR640T | Length 40 mm | In distribution |
| IS2-MR445T | Length 45 mm | In distribution |
| IS2-MR740T | Length 40 mm | In distribution |
| IS1-TRAY111 | In distribution | |
| IS1-TRAY115 | In distribution | |
| IS2-S860T | Diameter: 8.5 Milliimeters Length: 60 Milliimeters | In distribution |
| IS2-S535T | Diameter: 5.5 Milliimeters Length: 35 Milliimeters | In distribution |
| IS2-M435T | Diameter: 4.5 Milliimeters Length: 35 Milliimeters | In distribution |
| IS2-MR885T | Length 85 mm | In distribution |
| IS2-M885T | Diameter: 8.5 Milliimeters Length: 85 Milliimeters | In distribution |
| U1 – R606HC | Diameter: 6.0 Milliimeters Length: 60 Milliimeters | In distribution |
| IS2-MR755T | Length 55 mm | In distribution |
| IS2-M865T | Diameter: 8.5 Milliimeters Length: 65 Milliimeters | In distribution |
| IS2-MR1090T | Length 90 mm | In distribution |
| IS2-S1075T | Diameter: 10.5 Milliimeters Length: 75 Milliimeters | In distribution |
| IS2-MR1080T | Length 80 mm | In distribution |
| U1 – R610HC | Diameter: 6.0 Milliimeters Length: 100 Milliimeters | In distribution |
| IS2-MR880T | Outer Diameter 8.5 mm | In distribution |
| IS2-MR555T | Length 55 mm | In distribution |
| IS2-M1045T | Diameter: 10.5 Milliimeters Length: 45 Milliimeters | In distribution |
| IS2-MR845T | Outer Diameter 8.5 mm | In distribution |
| IS1-A316 | In distribution | |
| IS2-MR1075T | Length 75 mm | In distribution |
| IS2-MR1060T | Outer Diameter 10.5 mm | In distribution |
| IS1-A317 | In distribution | |
| IS1-A431 | Length: 170 Milliimeters, Width: 50 Milliimeters | In distribution |
| U1 – R630HC | Diameter: 6.0 Milliimeters Length: 300 Milliimeters | In distribution |
| IS2-S745T | Diameter: 7.5 Milliimeters Length: 45 Milliimeters | In distribution |
| IS2-MR435T | Length 35 mm | In distribution |
| IS2-MR530T | Length 30 mm | In distribution |
| IS2-M745T | Diameter: 7.5 Milliimeters Length: 45 Milliimeters | In distribution |
| IS2-MR865T | Length 65 mm | In distribution |
| IS2-A221-1 | In distribution | |
| IS2-MR525T | Length 25 mm | In distribution |
| IS2-MR735T | Length 35 mm | In distribution |
| IS2-M1040T | Diameter: 10.5 Milliimeters Length: 40 Milliimeters | In distribution |
| IS2-M440T | Diameter: 4.5 Milliimeters Length: 40 Milliimeters | In distribution |
| IS2-MR1065T | Length 65 mm | In distribution |
| IS2-MR1050T | Length 50 mm | In distribution |
| IS2-MR730T | Length 30 mm | In distribution |
| IS2-MR855T | Length 55 mm | In distribution |
| IS2-MR545T | Length 45 mm | In distribution |
| IS2-MR1030T | Outer Diameter 10.5 mm | In distribution |
| IS2-MR650T | Length 50 mm | In distribution |
| IS2-S645T | Diameter: 6.5 Milliimeters Length: 45 Milliimeters | In distribution |
| IS2-M1090T | Diameter: 10.5 Milliimeters Length: 90 Milliimeters | In distribution |
| IS1-A222 | Length: 180 Milliimeters, Diameter: 20 Milliimeters | In distribution |
| IS1-A225 | Diameter: 5,5 Milliimeters | In distribution |
| IS2-MR840T | Length 40 mm | In distribution |
| IS2-MR540T | Length 40 mm | In distribution |
| IS2-MR425T | Length 25 mm | In distribution |
| IS2-MR630T | Length 30 mm | In distribution |
| IS2-M445T | Diameter: 4.5 Milliimeters Length: 45 Milliimeters | In distribution |
| IS1-M545T | Diameter: 5.5 Milliimeters Length: 45 Milliimeters | In distribution |
| IS2-MR1040T | Length 40 mm | In distribution |
| IS2-MR655T | Length 55 mm | In distribution |
| IS2-MR750T | Length 50 mm | In distribution |
| IS2-S560T | Diameter: 5.5 Milliimeters Length: 60 Milliimeters | In distribution |
| IS2-M835T | Diameter: 8.5 Milliimeters Length: 35 Milliimeters | In distribution |
| IS2-MR870T | Length 70 mm | In distribution |
| U1 – R635HC | Diameter: 6.0 Milliimeters Length: 350 Milliimeters | In distribution |
| IS2-MR635T | Length 35 mm | In distribution |
| IS2-MR850T | Length 50 mm | In distribution |
| IS2-MR860T | Length 60 mm | In distribution |
| IS2-MR875T | Length 75 mm | In distribution |
| IS2-M1065T | Diameter: 10.5 Milliimeters Length: 65 Milliimeters | In distribution |
| IS2-MR645T | Length 45 mm | In distribution |
| IS2-MR1045T | Length 45 mm | 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
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.