Velofix™ PEEK Lumbar Cage
57 catalogue numbers from PLA1410, listed by CG MedTech Co., Ltd., South Korea, under Intervertebral Fusion Device With Bone Graft, Cervical. 7 manufacturers in China are registered for this product code.
Who Else Makes It
Concentrated in Shanghai (2), Shandong (2), Zhejiang (2). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Zhisu Health Tech Jiaxing Co., Ltd. | Tongxiang | Zhejiang | Contract manufacturer | 4 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Zhejiang Decans Medical Devices Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 10 |
| Shanghai Sanyou Medical Co., Ltd. | Shanghai | Shanghai | Manufacturer | 6 |
Record
| Listed by | CG MedTech Co., Ltd., South Korea |
|---|---|
| FDA product code | ODP |
| Device type | Intervertebral Fusion Device With Bone Graft, Cervical |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| Establishment | Complaint-file establishment, Manufacturer |
| 510(k) | K140864 |
| Record published | 2016-09-24 |
| Record revised | 2025-01-06 (version 8) |
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 |
| Storage | Special storage condition: Store in a cool dry place. |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PLA1410 | In distribution | |
| PLA2007 | In distribution | |
| PLA1811 | In distribution | |
| PLA1810 | In distribution | |
| PLA1413 | In distribution | |
| PLA2414 | In distribution | |
| PLA2008 | In distribution | |
| PLA1416 | In distribution | |
| PLA1007 | In distribution | |
| PLA3008 | In distribution | |
| PLA1809 | In distribution | |
| PLA2813 | In distribution | |
| PLA2016 | In distribution | |
| PLA2416 | In distribution | |
| PLA1813 | In distribution | |
| PLA3016 | In distribution | |
| PLA3013 | In distribution | |
| PLA1814 | In distribution | |
| PLA3014 | In distribution | |
| PLA2409 | In distribution | |
| PLA2810 | In distribution | |
| PLA2012 | In distribution | |
| PLA3012 | In distribution | |
| PLA2814 | In distribution | |
| PLA1011 | In distribution | |
| PLA1816 | In distribution | |
| PLA1412 | In distribution | |
| PLA1014 | In distribution | |
| PLA1408 | In distribution | |
| PLA1010 | In distribution | |
| PLA3009 | In distribution | |
| PLA3011 | In distribution | |
| PLA2812 | In distribution | |
| PLA2408 | In distribution | |
| PLA2014 | In distribution | |
| PLA1812 | In distribution | |
| PLA2009 | In distribution | |
| PLA1008 | In distribution | |
| PLA2010 | In distribution | |
| PLA1414 | In distribution | |
| PLA2011 | In distribution | |
| PLA2811 | In distribution | |
| PLA2410 | In distribution | |
| PLA2413 | In distribution | |
| PLA3007 | In distribution | |
| PLA1012 | In distribution | |
| PLA2411 | In distribution | |
| PLA2013 | In distribution | |
| PLA3010 | In distribution | |
| PLA2809 | In distribution | |
| PLA1409 | In distribution | |
| PLA2412 | In distribution | |
| PLA1411 | In distribution | |
| PLA2816 | In distribution | |
| PLA1013 | In distribution | |
| PLA1016 | In distribution | |
| PLA1009 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Latitude-C AM™ Cervical Interbody Fusion System | Degen Medical | 1,529 |
| IdentiTi | Alphatec Spine, Inc. | 1,390 |
| Zavation | Zavation | 1,357 |
| IVA Cage Ti | Diomedical Co., Ltd. | 1,202 |
| Latitude-C Cervical Interbody Spacer System | Degen Medical | 1,185 |
| Peridot Anterior Cervical Intervertebral Body Fusion System | Gbs Commonwealth Co., Ltd. | 1,056 |
| Aleutian® Interbody Systems | VB Spine LLC | 1,017 |
| Valeo Spacer System | Sintx Technologies Inc. | 918 |
| Cascadia™ Interbody System | VB Spine LLC | 823 |
| CoRoent | Nuvasive, Inc. | 815 |
| Tyber Medical | Tyber Medical | 740 |
| Matisse Anterior Cervical Interbody Fusion Cage System | CTL Medical Corporation | 577 |
Showing 12 of 938. All products under Intervertebral Fusion Device With Bone Graft, Cervical
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.