Elatus Lumbar Plate System
Variable Lumbar Plate Screw Dual Thread Ø 5.5x 30mm
14manufacturers in China registered for this device type
126catalogue numbers in this listing
1510(k) clearance
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 | Aegis Spine, United States |
|---|---|
| FDA product code | KWQ |
| Device type | Appliance, Fixation, Spinal Intervertebral Body |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3060 |
| 510(k) | K210035 |
| Record published | 2021-09-10 |
| Record revised | 2024-09-11 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5015-2840S | In distribution | |
| 7102-6020S | In distribution | |
| 7301-6030S | In distribution | |
| 2426-2034S | In distribution | |
| 7302-5530S | In distribution | |
| 7302-6045S | In distribution | |
| 2426-3044S | In distribution | |
| 5326-1832S | In distribution | |
| 5326-3852S | In distribution | |
| 7102-5555S | In distribution | |
| 5015-1426 | In distribution | |
| 2426-4054S | In distribution | |
| 7102-6040S | In distribution | |
| 7102-6035S | In distribution | |
| 7101-6025S | In distribution | |
| 5426-3246S | In distribution | |
| 7101-6050S | In distribution | |
| 5426-3044S | In distribution | |
| 5215-2638S | In distribution | |
| 5326-2236S | In distribution | |
| 2426-2236S | In distribution | |
| 7302-6030S | In distribution | |
| 5015-1830S | In distribution | |
| 2426-1832S | In distribution | |
| 7102-5525S | In distribution | |
| 7101-5540S | In distribution | |
| 5015-1527 | In distribution | |
| 5015-1426S | In distribution | |
| 5215-2032S | In distribution | |
| 7101-5555S | In distribution | |
| 5015-1628S | In distribution | |
| 7101-6035S | In distribution | |
| 5326-2842S | In distribution | |
| 5215-3648S | In distribution | |
| 7301-5535S | In distribution | |
| 2426-3246S | In distribution | |
| 5326-3650S | In distribution | |
| 7302-5555S | In distribution | |
| 7101-6030S | In distribution | |
| 5215-2436S | In distribution | |
| 5426-3852S | In distribution | |
| 5015-2436S | In distribution | |
| 5015-3042S | In distribution | |
| 7302-6020S | In distribution | |
| 5215-2234S | In distribution | |
| 7302-6040S | In distribution | |
| 7102-6045S | In distribution | |
| 7102-6025S | In distribution | |
| 7102-5545S | In distribution | |
| 7102-6055S | In distribution | |
| 2426-3650S | In distribution | |
| 2426-2438S | In distribution | |
| 5426-3650S | In distribution | |
| 7101-6040S | In distribution | |
| 5426-2236S | In distribution | |
| 7301-6025S | In distribution | |
| 7301-6055S | In distribution | |
| 5426-2640S | In distribution | |
| 7102-6030S | In distribution | |
| 7101-5535S | In distribution | |
| 7301-5540S | In distribution | |
| 7302-5550S | In distribution | |
| 5326-2034S | In distribution | |
| 5015-2234S | In distribution | |
| 2426-3852S | In distribution | |
| 2426-3448S | In distribution | |
| 7302-5525S | In distribution | |
| 7301-5545S | In distribution | |
| 7301-5550S | In distribution | |
| 7301-6045S | In distribution | |
| 7301-6020S | In distribution | |
| 5015-2638S | In distribution | |
| 7102-5550S | In distribution | |
| 7101-6045S | In distribution | |
| 7301-5525S | In distribution | |
| 5426-2438S | In distribution | |
| 7102-5535S | In distribution | |
| 7101-5550S | In distribution | |
| 5326-2640S | In distribution | |
| 7302-5545S | In distribution | |
| 2426-2842S | In distribution | |
| 5326-3448S | In distribution | |
| 5215-3042S | In distribution | |
| 7302-6035S | In distribution | |
| 7301-5520S | In distribution | |
| 5426-4054S | In distribution | |
| 5015-1527S | In distribution | |
| 5326-4054S | In distribution | |
| 7101-5525S | In distribution | |
| 7101-6055S | In distribution | |
| 5015-1830 | In distribution | |
| 5426-1832S | In distribution | |
| 5426-3448S | In distribution | |
| 5426-2034S | In distribution | |
| 7302-6055S | In distribution | |
| 5215-3446S | In distribution | |
| 7101-5530S | In distribution | |
| 5015-3648S | In distribution | |
| 7302-5535S | In distribution | |
| 7301-5555S | In distribution | |
| 7301-6050S | In distribution | |
| 2426-2640S | In distribution | |
| 5326-3246S | In distribution | |
| 7301-6040S | In distribution | |
| 5015-3446S | In distribution | |
| 7102-6050S | In distribution | |
| 7102-5540S | In distribution | |
| 7101-6020S | In distribution | |
| 7101-5545S | In distribution | |
| 5326-3044S | In distribution | |
| 5426-2842S | In distribution | |
| 7302-5540S | In distribution | |
| 5015-2032S | In distribution | |
| 7302-5520S | In distribution | |
| 5015-1628 | In distribution | |
| 5015-3244S | In distribution | |
| 7302-6025S | In distribution | |
| 5326-2438S | In distribution | |
| 7102-5530S | In distribution | |
| 7302-6050S | In distribution | |
| 7301-6035S | In distribution | |
| 5215-3244S | In distribution | |
| 7301-5530S | In distribution | |
| 7102-5520S | In distribution | |
| 5215-2840S | In distribution | |
| 7101-5520S | 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 |
|---|---|
| K223719 | 2023-01-11 |
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.