V-Strut Vertebral Implant
V-STRUT© Vertebral Implant 6.5-L45
5manufacturers in China registered for this device type
28catalogue numbers in this listing
2510(k) clearances naming this product code
Who Else Makes It
Concentrated in Shanghai (2), Jiangsu (1), Zhejiang (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Shanghai KiNETIC Medical Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Ningbo Hicren Biotechnology Co., Ltd. | Ningbo | Zhejiang | Manufacturer | 5 |
| Jieno Youcheng Medical Technology (Shanghai) Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 3 |
| Dragon Crown Medical Co., Ltd. | Jinan | Shandong | Manufacturer | 2 |
Record
| Listed by | Hyprevention, United States |
|---|---|
| FDA product code | NDN |
| Device type | Cement, Bone, Vertebroplasty |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3027 |
| Establishment | Manufacturer |
| Record published | 2020-07-10 |
| Record revised | 2025-12-17 (version 3) |
Specifications
| MRI safety | MR Safe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Sizes | Outer diameter 4.5 to 6.5 mm; length 25 to 60 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 36545 | Outer Diameter 6.5 mm | In distribution |
| 34535 | Outer Diameter 4.5 mm | In distribution |
| 35560 | Outer Diameter 5.5 mm | In distribution |
| 36540 | Outer Diameter 6.5 mm | In distribution |
| 35555 | Outer Diameter 5.5 mm | In distribution |
| 36560 | Outer Diameter 6.5 mm | In distribution |
| 34540 | Outer Diameter 4.5 mm | In distribution |
| 36545 | Outer Diameter 6.5 mm | In distribution |
| 34525 | Outer Diameter 4.5 mm | In distribution |
| 35550 | Outer Diameter 5.5 mm | In distribution |
| 36550 | Outer Diameter 6.5 mm | In distribution |
| 34555 | Outer Diameter 4.5 mm | In distribution |
| 36550 | Outer Diameter 6.5 mm | In distribution |
| 35545 | Outer Diameter 5.5 mm | In distribution |
| 36540 | Outer Diameter 6.5 mm | In distribution |
| 35540 | Outer Diameter 5.5 mm | In distribution |
| 36560 | Outer Diameter 6.5 mm | In distribution |
| 34550 | Outer Diameter 4.5 mm | In distribution |
| 36555 | Outer Diameter 6.5 mm | In distribution |
| 35545 | Outer Diameter 5.5 mm | In distribution |
| 35555 | Outer Diameter 5.5 mm | In distribution |
| 34545 | Outer Diameter 4.5 mm | In distribution |
| 36555 | Outer Diameter 6.5 mm | In distribution |
| 34530 | Outer Diameter 4.5 mm | In distribution |
| 35540 | Outer Diameter 5.5 mm | In distribution |
| 34560 | Outer Diameter 4.5 mm | In distribution |
| 35550 | Outer Diameter 5.5 mm | In distribution |
| 35560 | Outer Diameter 5.5 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Zavation | Zavation | 284 |
| CD Horizon® Fenestrated Screw Set | Medtronic Sofamor Danek, Inc. | 88 |
| StabiliT® | Merit Medical Systems, Inc. | 42 |
| Medinaut Plus Kyphoplasty System | Imedicom Co., Ltd. | 41 |
| iVAS | Stryker GmbH | 35 |
| Tracker Plus Kyphoplasty System | GS Medical Co., Ltd. | 25 |
| StabiliT MX Fracture Kit | Dfine, Inc. | 12 |
| Osseoflex® | Merit Medical Systems, Inc. | 8 |
| Synth™ BES | Imedicom Co., Ltd. | 8 |
| Tracker | GS Medical Co., Ltd. | 6 |
| AVAflex | Stryker GmbH | 6 |
| Spider Kolibri | Sintea Plustek | 6 |
Showing 12 of 210. All products under Cement, Bone, Vertebroplasty
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K240084 | 2024-02-09 |
| K191709 | 2020-03-05 |
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.