Velofix™ SA Cervical Cage
122 catalogue numbers from RSA161206, listed by CG MedTech Co., Ltd., South Korea, under Intervertebral Fusion Device With Integrated Fixation, Cervical. 5 manufacturers in China are registered for this product code.
5manufacturers in China registered for this device type
122catalogue numbers in this listing
1recall
Who Else Makes It
Concentrated in Zhejiang (2), Guangdong (1), Jiangsu (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Zhisu Health Tech Jiaxing Co., Ltd. | Tongxiang | Zhejiang | Contract manufacturer | 4 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Zhejiang Decans Medical Devices Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 10 |
Record
| Listed by | CG MedTech Co., Ltd., South Korea |
|---|---|
| FDA product code | OVE |
| Device type | Intervertebral Fusion Device With Integrated Fixation, Cervical |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| Establishment | Complaint-file establishment, Manufacturer |
| 510(k) | K172424 |
| Record published | 2018-06-23 |
| Record revised | 2025-01-06 (version 5) |
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 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| RSA161206 | In distribution | |
| TSA6210 | In distribution | |
| TS4018FT | In distribution | |
| TSA6611S | In distribution | |
| TSA1000 | In distribution | |
| TS4010FT | In distribution | |
| TSA1000 | In distribution | |
| TSA6209S | In distribution | |
| TS4016FT | In distribution | |
| TS4017FD | In distribution | |
| TSA6207S | In distribution | |
| RSA161411 | In distribution | |
| TSA6408 | In distribution | |
| TSA6211S | In distribution | |
| TSA6207 | In distribution | |
| RSA161207 | In distribution | |
| TSA6606 | In distribution | |
| TSA161407 | In distribution | |
| TSA161210 | In distribution | |
| TSA6406 | In distribution | |
| TS4014FD | In distribution | |
| TS1805S | In distribution | |
| TS3516FT | In distribution | |
| TSA6205S | In distribution | |
| TSA6611 | In distribution | |
| TS3511FT | In distribution | |
| TS4020FD | In distribution | |
| TS1811S | In distribution | |
| TS1810S | In distribution | |
| TSA6206S | In distribution | |
| TSA6608S | In distribution | |
| TSA6610S | In distribution | |
| TSA161211 | In distribution | |
| TS3510FT | In distribution | |
| TS4011FD | In distribution | |
| TS3517FT | In distribution | |
| TSA6605S | In distribution | |
| TS3519FD | In distribution | |
| TSA6608 | In distribution | |
| TSA6208 | In distribution | |
| TS3514FT | In distribution | |
| TSA6206 | In distribution | |
| TS3520FT | In distribution | |
| TSA161206 | In distribution | |
| TS3512FD | In distribution | |
| TSA6405 | In distribution | |
| TSA161205 | In distribution | |
| TS3520FD | In distribution | |
| TSA6407S | In distribution | |
| TSA6210S | In distribution | |
| TSA6205 | In distribution | |
| TSA161209 | In distribution | |
| TSA6605 | In distribution | |
| TS4014FT | In distribution | |
| TSA161410 | In distribution | |
| RSA161210 | In distribution | |
| TSA6411 | In distribution | |
| TS4013FD | In distribution | |
| TSA6409S | In distribution | |
| TS3519FT | In distribution | |
| TS3517FD | In distribution | |
| TSA6606S | In distribution | |
| TS3510FD | In distribution | |
| TSA6407 | In distribution | |
| RSA161208 | In distribution | |
| TSA6211 | In distribution | |
| RSA161406 | In distribution | |
| TS1809S | In distribution | |
| TSA161411 | In distribution | |
| RSA161211 | In distribution | |
| TS3512FT | In distribution | |
| TSA161405 | In distribution | |
| TS4016FD | In distribution | |
| TSA6405S | In distribution | |
| TSA161408 | In distribution | |
| TS4010FD | In distribution | |
| TS4017FT | In distribution | |
| TSA6410S | In distribution | |
| TS3515FD | In distribution | |
| TS4018FD | In distribution | |
| TSA6410 | In distribution | |
| TSA6409 | In distribution | |
| TSA6209 | In distribution | |
| TS4012FD | In distribution | |
| TSA6607S | In distribution | |
| TS3518FT | In distribution | |
| TS4015FD | In distribution | |
| TSA6411S | In distribution | |
| TS3513FD | In distribution | |
| TSA161406 | In distribution | |
| RSA161407 | In distribution | |
| TS1807S | In distribution | |
| TS3514FD | In distribution | |
| TS3516FD | In distribution | |
| TS4011FT | In distribution | |
| TS1808S | In distribution | |
| TSA161409 | In distribution | |
| TSA6406S | In distribution | |
| TS4013FT | In distribution | |
| TSA6408S | In distribution | |
| TSA161208 | In distribution | |
| TS4019FD | In distribution | |
| RSA1000 | In distribution | |
| TSA161207 | In distribution | |
| RSA161209 | In distribution | |
| TS4019FT | In distribution | |
| TSA6609 | In distribution | |
| RSA161409 | In distribution | |
| TSA6609S | In distribution | |
| TSA6607 | In distribution | |
| TS1806S | In distribution | |
| TS4012FT | In distribution | |
| TSA6610 | In distribution | |
| TSA6208S | In distribution | |
| TS3515FT | In distribution | |
| TS3518FD | In distribution | |
| RSA161408 | In distribution | |
| TS3513FT | In distribution | |
| TS3511FD | In distribution | |
| TS4015FT | In distribution | |
| TS4020FT | In distribution | |
| RSA161410 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| IdentiTi | Alphatec Spine, Inc. | 630 |
| Dolomite | Astura Medical | 607 |
| CoRoent | Nuvasive, Inc. | 580 |
| Aeon-C | Diomedical Co., Ltd. | 508 |
| Tomcat™ Cervical Spinal System | Choice Spine, LP | 468 |
| Shoreline ACS | Seaspine Orthopedics Corporation | 428 |
| Zavation | Zavation | 423 |
| Alta™ Stand-Alone Interbody Fusion System | Biomet Spine | 404 |
| Unison™-C Anterior Cervical Fixation System | Pioneer Surgical Technology, Inc. | 334 |
| Chesapeake® Stabilization System | VB Spine LLC | 272 |
| UniSpace® Stand-Alone C Cage | CG MedTech Co., Ltd. | 260 |
| Solitaire-C Cervical Spacer | Biomet Spine | 256 |
Showing 12 of 391. All products under Intervertebral Fusion Device With Integrated Fixation, Cervical
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| CG MedTech Co., Ltd. | 510(k) number | 2019-01-30 | Class II | Employee error | The vertical dimensions of screw-hole position in some standalone cages might be out of range in engineering drawings. A possibility exists of screw pullout, lossening, instability, or less bone-screw engagement than intended by physicians. | 42 | 2020-11-20 |
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.