Appliance, Fixation, Spinal Intervertebral Body
Cervical Plate, 4 Level 60.5mm x 2.10mm
14manufacturers in China registered for this device type
99catalogue 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 | TDM Co., Ltd., South Korea |
|---|---|
| FDA product code | KWQ |
| Device type | Appliance, Fixation, Spinal Intervertebral Body |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3060 |
| Establishment | Manufacturer |
| 510(k) | K240423 |
| Record published | 2026-06-05 |
| Record revised | 2026-06-17 (version 2) |
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, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2212-0482 | In distribution | |
| 1212-4018 | In distribution | |
| 1212-3512 | In distribution | |
| 1215-3510 | In distribution | |
| 2212-0244 | In distribution | |
| 2212-0366 | In distribution | |
| 2212-0250 | In distribution | |
| 1212-4012 | In distribution | |
| 1213-4014 | In distribution | |
| 2212-0376 | In distribution | |
| 2212-0460 | In distribution | |
| 1212-3514 | In distribution | |
| 1214-4010 | In distribution | |
| 2212-0486 | In distribution | |
| 2212-0356 | In distribution | |
| 1214-4020 | In distribution | |
| 1213-3516 | In distribution | |
| 1214-3520 | In distribution | |
| 1213-3520 | In distribution | |
| 1215-3516 | In distribution | |
| 1212-3520 | In distribution | |
| 2212-0370 | In distribution | |
| 1215-4020 | In distribution | |
| 2212-0474 | In distribution | |
| 2212-0456 | In distribution | |
| 1213-3510 | In distribution | |
| 2212-0246 | In distribution | |
| 2212-0242 | In distribution | |
| 2212-0462 | In distribution | |
| 2212-0372 | In distribution | |
| 2212-0358 | In distribution | |
| 1215-4012 | In distribution | |
| 1212-4014 | In distribution | |
| 2212-0118 | In distribution | |
| 1214-4012 | In distribution | |
| 1212-3510 | In distribution | |
| 2212-0468 | In distribution | |
| 2212-0466 | In distribution | |
| 2212-0470 | In distribution | |
| 2212-0252 | In distribution | |
| 1215-4018 | In distribution | |
| 1212-4020 | In distribution | |
| 2212-0132 | In distribution | |
| 2212-0254 | In distribution | |
| 2212-0362 | In distribution | |
| 2212-0240 | In distribution | |
| 2212-0352 | In distribution | |
| 2212-0368 | In distribution | |
| 1213-3518 | In distribution | |
| 1215-3520 | In distribution | |
| 2212-0374 | In distribution | |
| 2212-0478 | In distribution | |
| 2212-0378 | In distribution | |
| 1212-3516 | In distribution | |
| 2212-0134 | In distribution | |
| 1212-3518 | In distribution | |
| 2212-0130 | In distribution | |
| 2212-0364 | In distribution | |
| 2212-0124 | In distribution | |
| 2212-0464 | In distribution | |
| 1212-4016 | In distribution | |
| 1214-3514 | In distribution | |
| 1214-4014 | In distribution | |
| 1213-4010 | In distribution | |
| 1212-4010 | In distribution | |
| 1213-4020 | In distribution | |
| 2212-0126 | In distribution | |
| 2212-0346 | In distribution | |
| 1213-4016 | In distribution | |
| 1213-3514 | In distribution | |
| 2212-0354 | In distribution | |
| 1214-3510 | In distribution | |
| 1213-4018 | In distribution | |
| 2212-0120 | In distribution | |
| 2212-0234 | In distribution | |
| 2212-0236 | In distribution | |
| 1214-4016 | In distribution | |
| 2212-0350 | In distribution | |
| 1215-4014 | In distribution | |
| 2212-0360 | In distribution | |
| 2212-0232 | In distribution | |
| 2212-0490 | In distribution | |
| 1215-4010 | In distribution | |
| 1214-3516 | In distribution | |
| 2212-0238 | In distribution | |
| 1213-3512 | In distribution | |
| 1213-4012 | In distribution | |
| 1215-4016 | In distribution | |
| 1214-3518 | In distribution | |
| 1215-3512 | In distribution | |
| 1214-3512 | In distribution | |
| 2212-0122 | In distribution | |
| 1215-3514 | In distribution | |
| 1215-3518 | In distribution | |
| 2212-0458 | In distribution | |
| 2212-0128 | In distribution | |
| 1214-4018 | In distribution | |
| 2212-0248 | In distribution | |
| 2212-0348 | 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 |
|---|---|
| K240423 | 2024-04-08 |
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.