Dynamo
4 catalogue numbers from Spinal Cement – MV, listed by Teknimed SAS, France, under Cement, Bone, Vertebroplasty. 5 manufacturers in China are registered for this product code.
5manufacturers in China registered for this device type
4catalogue numbers in this listing
2510(k) clearances naming this product code
1recall
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 | Teknimed SAS, France |
|---|---|
| FDA product code | NDN |
| Device type | Cement, Bone, Vertebroplasty |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3027 |
| Establishment | Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2026-02-02 |
Specifications
| MRI safety | MR Safe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature up to 25 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Spinal Cement → MV | In distribution | |
| Spinal Cement System Syringe MV 1.5cc | In distribution | |
| Spinal Cement System Syringe MV 4cc | In distribution | |
| Spinal Cement System Gun MV | 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 |
| V-Strut Vertebral Implant | Hyprevention | 28 |
| 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 |
Showing 12 of 210. All products under Cement, Bone, Vertebroplasty
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K161114 | 2017-04-12 |
| K103816 | 2011-02-04 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2022-12-15 | Class II | Employee error | Incorrect expiry date. Product is labeled with expiry date 2027-02-28. The correct expiration date is 2025-02-28. | 236 systems |
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.