Lumbar Plate
1 Level Lumbar Plate Four Bore Drill Guide 34mm Orthogonal
14manufacturers in China registered for this device type
194catalogue 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 | Genesys Orthopedics Systems, LLC |
|---|---|
| FDA product code | KWQ |
| Device type | Appliance, Fixation, Spinal Intervertebral Body |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3060 |
| 510(k) | K173885 |
| Record published | 2018-11-08 |
| Record revised | 2024-09-11 (version 6) |
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, expiry date, manufacturing date |
| Sizes | Length 5 to 108 mm; outer diameter 5.5 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1 | In distribution | |
| 1 | Length 62 mm | In distribution |
| 1 | In distribution | |
| 1 | Length 18 mm | In distribution |
| 1 | Length 30 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Length 48 mm | In distribution |
| 1 | Length 50 mm | In distribution |
| 1 | Length 26 mm | In distribution |
| 1 | Length 74 mm | In distribution |
| 1 | Length 38 mm | In distribution |
| 1 | Length 22 mm | In distribution |
| 1 | Length 46 mm | In distribution |
| 1 | Length 13 mm | In distribution |
| 1 | Length 19 mm | In distribution |
| 1 | Length 18 mm | In distribution |
| 1 | Length 68 mm | In distribution |
| 1 | In distribution | |
| 1 | Length 22 mm | In distribution |
| 1 | Length 26 mm | In distribution |
| 1 | In distribution | |
| 1 | Length 12 mm | In distribution |
| 1 | Length 20 mm | In distribution |
| 1 | Length 86 mm | In distribution |
| 1 | Length 37 mm | In distribution |
| 1 | In distribution | |
| 1 | Length 20 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Length 17 mm | In distribution |
| 1 | Length 16 mm | In distribution |
| 1 | In distribution | |
| 1 | Length 28 mm | In distribution |
| 1 | Length 100 mm | In distribution |
| 1 | In distribution | |
| 1 | Length 25 mm | In distribution |
| 1 | Outer Diameter 5.5 mm | In distribution |
| 1 | In distribution | |
| 1 | Length 80 mm | In distribution |
| 1 | Outer Diameter 5.5 mm | In distribution |
| 1 | Length 34 mm | In distribution |
| 1 | In distribution | |
| 1 | Length 19 mm | In distribution |
| 1 | In distribution | |
| 1 | Length 40 mm | In distribution |
| 1 | Length 10 mm | In distribution |
| 1 | Length 52 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Length 38 mm | In distribution |
| 1 | In distribution | |
| 1 | Length 50 mm | In distribution |
| 1 | Length 25 mm | In distribution |
| 1 | Length 16 mm | In distribution |
| 1 | Length 8 mm | In distribution |
| 1 | Length 9 mm | In distribution |
| 1 | Outer Diameter 5.5 mm | In distribution |
| 1 | In distribution | |
| 1 | Length 11 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Length 12 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Length 50 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Length 72 mm | In distribution |
| 1 | Length 13 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Length 104 mm | In distribution |
| 1 | In distribution | |
| 1 | Length 34 mm | In distribution |
| 1 | Length 38 mm | In distribution |
| 1 | Length 22 mm | In distribution |
| 1 | Length 28 mm | In distribution |
| 1 | Length 34 mm | In distribution |
| 1 | Length 80 mm | In distribution |
| 1 | In distribution | |
| 1 | Length 40 mm | In distribution |
| 1 | Outer Diameter 5.5 mm | In distribution |
| 1 | In distribution | |
| 1 | Length 22 mm | In distribution |
| 1 | Length 31 mm | In distribution |
| 1 | In distribution | |
| 1 | Length 40 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Length 92 mm | In distribution |
| 1 | Length 30 mm | In distribution |
| 1 | In distribution | |
| 1 | Outer Diameter 5.5 mm | In distribution |
| 1 | Length 76 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Length 26 mm | In distribution |
| 1 | In distribution | |
| 1 | Length 15 mm | In distribution |
| 1 | In distribution | |
| 1 | Length 22 mm | In distribution |
| 1 | In distribution | |
| 1 | Length 31 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Length 96 mm | In distribution |
| 1 | In distribution | |
| 1 | Outer Diameter 5.5 mm | In distribution |
| 1 | Outer Diameter 5.5 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Length 25 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Length 54 mm | In distribution |
| 1 | In distribution | |
| 1 | Length 68 mm | In distribution |
| 1 | Outer Diameter 5.5 mm | In distribution |
| 1 | Length 60 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Length 5 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Length 84 mm | In distribution |
| 1 | Outer Diameter 5.5 mm | In distribution |
| 1 | Length 34 mm | In distribution |
| 1 | Length 6 mm | In distribution |
| 1 | In distribution | |
| 1 | Length 37 mm | In distribution |
| 1 | Length 42 mm | In distribution |
| 1 | Length 54 mm | In distribution |
| 1 | Length 42 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Length 15 mm | In distribution |
| 1 | In distribution | |
| 1 | Outer Diameter 5.5 mm | In distribution |
| 1 | Length 11 mm | In distribution |
| 1 | Length 19 mm | In distribution |
| 1 | Length 88 mm | In distribution |
| 1 | Length 31 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Length 108 mm | In distribution |
| 1 | Length 7 mm | In distribution |
| 1 | Length 34 mm | In distribution |
| 1 | In distribution | |
| 1 | Length 64 mm | In distribution |
| 1 | In distribution | |
| 1 | Length 17 mm | In distribution |
| 1 | Length 37 mm | In distribution |
| 1 | In distribution | |
| 1 | Length 18 mm | In distribution |
| 1 | Length 76 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Outer Diameter 5.5 mm | In distribution |
| 1 | Length 18 mm | In distribution |
| 1 | Length 14 mm | In distribution |
| 1 | Length 44 mm | In distribution |
| 1 | In distribution | |
| 1 | Length 10 mm | In distribution |
| 1 | In distribution | |
| 1 | Outer Diameter 5.5 mm | In distribution |
| 1 | Length 50 mm | In distribution |
| 1 | Length 40 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Outer Diameter 5.5 mm | In distribution |
| 1 | Length 46 mm | In distribution |
| 1 | Length 56 mm | In distribution |
| 1 | Length 34 mm | In distribution |
| 1 | Length 14 mm | In distribution |
| 1 | In distribution | |
| 1 | Length 28 mm | In distribution |
| 1 | In distribution | |
| 1 | Outer Diameter 5.5 mm | In distribution |
| 1 | Length 30 mm | In distribution |
| 1 | In distribution | |
| 1 | Outer Diameter 5.5 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.