Lumis™
MULTI-AXIAL SCREW, DIAMETER 6.5mm, LENGTH 35mm
14manufacturers in China registered for this device type
45catalogue 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) | K130302 |
| Record published | 2015-10-15 |
| Record revised | 2025-01-07 (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 |
| Sizes | Length 30 to 35 mm; outer diameter 6 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MS1-R6085T | Diameter: 6.0 Milliimeters Length: 85 Milliimeters | In distribution |
| MS1-M635T | Diameter: 6.5 Milliimeters, Length: 35 Milliimeters | In distribution |
| MS2-M540T | Diameter: 5.5 Milliimeters Length: 40 Milliimeters | In distribution |
| MS1-R6075T | Diameter: 6.0 Milliimeters Length: 75 Milliimeters | In distribution |
| MS2-M740T | Diameter: 7.5 Milliimeters Length: 40 Milliimeters | In distribution |
| MS2-S660T | Diameter: 6.5 Milliimeters, Length: 60 Milliimeters | In distribution |
| MS2-S530T | Diameter: 5.5 Milliimeters, Length: 30 Milliimeters | In distribution |
| MS1-M660T | Diameter: 6.5 Milliimeters, Length: 60 Milliimeters | In distribution |
| MS1-R6045CT | Diameter: 6.0 Milliimeters Length: 45 Milliimeters | In distribution |
| MS2-S880T | Diameter: 8.5 Milliimeters, Length: 80 Milliimeters | In distribution |
| MS2-M640T | Diameter: 6.5 Milliimeters Length: 40 Milliimeters | In distribution |
| MS1-A335 | Length: 74 Milliimeters, Width: 13 Milliimeters, Height: 8 Milliimeters | In distribution |
| MS1-R6030CT | Length 30 mm | In distribution |
| MS1-A118 | Diameter: 8 Milliimeters | In distribution |
| MS1-A222 | Length: 211 Milliimeters, Width: 90 Milliimeters | In distribution |
| MS1-R6055CT | Diameter: 6.0 Milliimeters Length: 55 Milliimeters | In distribution |
| MS2-M890T | Diameter: 8.5 Milliimeters Length: 90 Milliimeters | In distribution |
| MS1-R6095T | Diameter: 6.0 Milliimeters Length: 95 Milliimeters | In distribution |
| MS1R6030T | Diameter: 6.0 Millimeters Length: 30 Millimeters | In distribution |
| MS1-R6070T | Diameter: 6.0 Milliimeters Length: 70 Milliimeters | In distribution |
| MS1-M535T | Diameter: 5.5 Milliimeters, Length: 35 Milliimeters | In distribution |
| MS1-A232 | Width : 20 Milliimeters, Height : 15 Milliimeters | In distribution |
| MS1-A110 | Diameter: 6 Milliimeters, Length: 160 Milliimeters | In distribution |
| MS1-A211 | Diameter: 20 Milliimeters , Length: 165 Milliimeters | In distribution |
| MS2-M760T | Diameter: 7.5 Milliimeters Length: 60 Milliimeters | In distribution |
| MS2-S735T | Diameter: 7.5 Milliimeters, Length: 35 Milliimeters | In distribution |
| MS2-M560T | Diameter: 5.5 Milliimeters Length: 60 Milliimeters | In distribution |
| MS2-S845T | Diameter: 8.5 Milliimeters, Length: 45 Milliimeters | In distribution |
| MS2-S555T | Diameter: 5.5 Milliimeters, Length: 55 Milliimeters | In distribution |
| MS1-R6135CT | Diameter: 6.0 Milliimeters Length: 135 Milliimeters | In distribution |
| MS2-M865T | Diameter: 8.5 Milliimeters Length: 65 Milliimeters | In distribution |
| MS1-R6035T | Outer Diameter 6.0 mm | In distribution |
| MS2-M650T | Diameter: 6.5 Milliimeters Length: 50 Milliimeters | In distribution |
| MS2-S550T | Diameter: 5.5 Milliimeters, Length: 50 Milliimeters | In distribution |
| MS1-R6060CT | Diameter: 6.0 Milliimeters Length: 60 Milliimeters | In distribution |
| MS2-M545T | Diameter: 5.5 Milliimeters Length: 45 Milliimeters | In distribution |
| MS1-A261 | Length : 300 Milliimeters , Width : 80 Milliimeters | In distribution |
| MS1-A113 | Diameter: 25 Milliimeters, Length: 120 Milliimeters | In distribution |
| MS1-R6035CT | Length 35 mm | In distribution |
| MS1-R6110T | Diameter: 6.0 Milliimeters Length: 110 Milliimeters | In distribution |
| MS2-M880T | Diameter: 8.5 Milliimeters Length: 80 Milliimeters | In distribution |
| MS2-M635T | Diameter: 6.5 Milliimeters Length: 35 Milliimeters | In distribution |
| MS1-R6070CT | Diameter: 6.0 Milliimeters Length: 70 Milliimeters | In distribution |
| MS2-M840T | Diameter: 8.5 Milliimeters L40 Milliimeters | In distribution |
| MS1-R6130CT | Diameter: 6.0 Milliimeters Length: 130 Milliimeters | 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.