Vault C Acdf System
Standard Implant Kit + 18x15 implants and trials + Directional Blade
5manufacturers in China registered for this device type
95catalogue numbers in this listing
1510(k) clearance
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 | Precision Spine, Inc., United States |
|---|---|
| FDA product code | OVE |
| Device type | Intervertebral Fusion Device With Integrated Fixation, Cervical |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| Establishment | Manufacturer |
| 510(k) | K132029 |
| Record published | 2019-04-05 |
| Record revised | 2025-11-20 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 37-CL-4208 | In distribution | |
| 37-SD-4017 | In distribution | |
| 37-PA-4211 | In distribution | |
| 37-PA-6411 | In distribution | |
| 37-CL-6407 | In distribution | |
| 37-PA-6409 | In distribution | |
| 37-PA-6406 | In distribution | |
| 37-PA-8508 | In distribution | |
| 37-PA-6407 | In distribution | |
| 37-SB-4017 | In distribution | |
| 37-CL-8507 | In distribution | |
| 37-PA-8510 | In distribution | |
| 37-PA-8507 | In distribution | |
| 37-PA-6410 | In distribution | |
| 37-CL-6409 | In distribution | |
| 37-CP-4211 | In distribution | |
| 37-CL-4210 | In distribution | |
| 37-PA-8506 | In distribution | |
| 37-SC-0203 | In distribution | |
| 37-CP-8512 | In distribution | |
| 37-SD-4015 | In distribution | |
| 37-SC-0201 | In distribution | |
| 37-CL-4211 | In distribution | |
| 37-PA-4209 | In distribution | |
| 37-CP-8510 | In distribution | |
| 37-SB-4012 | In distribution | |
| 37-SC-0202 | In distribution | |
| 37-CL-4209 | In distribution | |
| 37-PA-8511 | In distribution | |
| 37-BK-0212 | In distribution | |
| 37-CP-8511 | In distribution | |
| 37-SC-0110 | In distribution | |
| 37-CP-4208 | In distribution | |
| 37-CP-6412 | In distribution | |
| 37-SC-0102 | In distribution | |
| 37-CP-4207 | In distribution | |
| 37-BK-0102 | In distribution | |
| 37-CL-6408 | In distribution | |
| 37-PA-8512 | In distribution | |
| 37-SD-4012 | In distribution | |
| 37-CL-8506 | In distribution | |
| 37-SC-0103 | In distribution | |
| 37-BK-0211 | In distribution | |
| 37-SD-3517 | In distribution | |
| 37-PA-4207 | In distribution | |
| 37-CP-8506 | In distribution | |
| 37-CL-4212 | In distribution | |
| 37-PA-6408 | In distribution | |
| 37-CP-4209 | In distribution | |
| 37-CL-6411 | In distribution | |
| 37-SD-3515 | In distribution | |
| 37-BK-0101 | In distribution | |
| 37-SB-3514 | In distribution | |
| 37-PA-4212 | In distribution | |
| 37-PA-4210 | In distribution | |
| 37-CP-8507 | In distribution | |
| 37-SC-0101 | In distribution | |
| 37-CL-8512 | In distribution | |
| 37-SB-3515 | In distribution | |
| 37-BK-0201 | In distribution | |
| 37-BK-0103 | In distribution | |
| 37-CL-4206 | In distribution | |
| 37-CP-6409 | In distribution | |
| 37-PA-4206 | In distribution | |
| 37-CP-8509 | In distribution | |
| 37-SB-3512 | In distribution | |
| 37-CP-4206 | In distribution | |
| 37-CP-8508 | In distribution | |
| 37-SD-4014 | In distribution | |
| 37-CP-4212 | In distribution | |
| 37-PA-4208 | In distribution | |
| 37-CL-8511 | In distribution | |
| 37-BK-0104 | In distribution | |
| 37-SB-3517 | In distribution | |
| 37-CP-4210 | In distribution | |
| 37-SD-3514 | In distribution | |
| 37-CP-6411 | In distribution | |
| 37-CL-6406 | In distribution | |
| 37-SD-3512 | In distribution | |
| 37-PA-8509 | In distribution | |
| 37-CL-4207 | In distribution | |
| 37-CL-8510 | In distribution | |
| 37-CL-6410 | In distribution | |
| 37-SC-0100 | In distribution | |
| 37-CP-6406 | In distribution | |
| 37-SC-0104 | In distribution | |
| 37-CL-6412 | In distribution | |
| 37-SB-4015 | In distribution | |
| 37-CP-6408 | In distribution | |
| 37-CP-6410 | In distribution | |
| 37-PA-6412 | In distribution | |
| 37-CL-8509 | In distribution | |
| 37-CL-8508 | In distribution | |
| 37-CP-6407 | In distribution | |
| 37-SB-4014 | 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K203129 | 2021-01-12 |
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.