Zavation ZVplasty System Assembly
ZVplasty System Assembly
5manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
40recalls on this 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 | Zavation, United States |
|---|---|
| FDA product code | NDN |
| Device type | Cement, Bone, Vertebroplasty |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3027 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K141419 |
| Record published | 2024-11-01 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| VCF-1015-1-E | 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 |
|---|---|
| K141419 | 2014-09-12 |
Recalls Naming This Product
36 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Zavation | 510(k) number | 2021-03-25 | Class II | Vendor change control | Products distributed as sterile may not have been adequately sterilized | 56 units | 2023-03-20 |
| Zavation | 510(k) number | 2021-03-25 | Class II | Vendor change control | Products distributed as sterile may not have been adequately sterilized | 38 units | 2023-03-20 |
| Zavation | 510(k) number | 2021-03-25 | Class II | Vendor change control | Products distributed as sterile may not have been adequately sterilized | 335 units | 2023-03-20 |
| Zavation | 510(k) number | 2021-03-25 | Class II | Vendor change control | Products distributed as sterile may not have been adequately sterilized | 88 units | 2023-03-20 |
| Zavation | 510(k) number | 2021-03-25 | Class II | Vendor change control | Products distributed as sterile may not have been adequately sterilized | 14 units | 2023-03-20 |
| Zavation | 510(k) number | 2021-03-25 | Class II | Vendor change control | Products distributed as sterile may not have been adequately sterilized | 2023-03-20 | |
| Zavation | 510(k) number | 2021-03-25 | Class II | Vendor change control | Products distributed as sterile may not have been adequately sterilized | 2 units | 2023-03-20 |
| Zavation | 510(k) number | 2021-03-25 | Class II | Vendor change control | Products distributed as sterile may not have been adequately sterilized | 11 units | 2023-03-20 |
| Zavation | 510(k) number | 2021-03-25 | Class II | Vendor change control | Products distributed as sterile may not have been adequately sterilized | 72 units | 2023-03-20 |
| Zavation | 510(k) number | 2021-03-25 | Class II | Vendor change control | Products distributed as sterile may not have been adequately sterilized | 1 unit | 2023-03-20 |
| Zavation | 510(k) number | 2021-03-25 | Class II | Vendor change control | Products distributed as sterile may not have been adequately sterilized | 98 units | 2023-03-20 |
| Zavation | 510(k) number | 2021-03-25 | Class II | Vendor change control | Products distributed as sterile may not have been adequately sterilized | 113 units | 2023-03-20 |
| Zavation | 510(k) number | 2021-03-25 | Class II | Vendor change control | Products distributed as sterile may not have been adequately sterilized | 15 units | 2023-03-20 |
| Zavation | 510(k) number | 2021-03-25 | Class II | Vendor change control | Products distributed as sterile may not have been adequately sterilized | 72 units | 2023-03-20 |
| Zavation | 510(k) number | 2021-03-25 | Class II | Vendor change control | Products distributed as sterile may not have been adequately sterilized | 162 units | 2023-03-20 |
| Zavation | 510(k) number | 2021-03-25 | Class II | Vendor change control | Products distributed as sterile may not have been adequately sterilized | 34 units | 2023-03-20 |
| Zavation | 510(k) number | 2021-03-25 | Class II | Vendor change control | Products distributed as sterile may not have been adequately sterilized | 98 units | 2023-03-20 |
| Zavation | 510(k) number | 2021-03-25 | Class II | Vendor change control | Products distributed as sterile may not have been adequately sterilized | 27 units | 2023-03-20 |
| Zavation | 510(k) number | 2021-03-25 | Class II | Vendor change control | Products distributed as sterile may not have been adequately sterilized | 11 units | 2023-03-20 |
| Zavation | 510(k) number | 2021-03-25 | Class II | Vendor change control | Products distributed as sterile may not have been adequately sterilized | 113 units | 2023-03-20 |
| Zavation | 510(k) number | 2021-03-25 | Class II | Vendor change control | Products distributed as sterile may not have been adequately sterilized | 15 units | 2023-03-20 |
| Zavation | 510(k) number | 2021-03-25 | Class II | Vendor change control | Products distributed as sterile may not have been adequately sterilized | 22 units | 2023-03-20 |
| Zavation | 510(k) number | 2021-03-25 | Class II | Vendor change control | Products distributed as sterile may not have been adequately sterilized | 2023-03-20 | |
| Zavation | 510(k) number | 2021-03-25 | Class II | Vendor change control | Products distributed as sterile may not have been adequately sterilized | 2023-03-20 | |
| Zavation | 510(k) number | 2021-03-25 | Class II | Vendor change control | Products distributed as sterile may not have been adequately sterilized | 2023-03-20 | |
| Zavation | 510(k) number | 2021-03-25 | Class II | Vendor change control | Products distributed as sterile may not have been adequately sterilized | 2023-03-20 | |
| Zavation | 510(k) number | 2021-03-25 | Class II | Vendor change control | Products distributed as sterile may not have been adequately sterilized | 2023-03-20 | |
| Zavation | 510(k) number | 2021-03-25 | Class II | Vendor change control | Products distributed as sterile may not have been adequately sterilized | 2023-03-20 | |
| Zavation | 510(k) number | 2021-03-25 | Class II | Vendor change control | Products distributed as sterile may not have been adequately sterilized | 2023-03-20 | |
| Zavation | 510(k) number | 2021-03-25 | Class II | Vendor change control | Products distributed as sterile may not have been adequately sterilized | 2023-03-20 | |
| Zavation | 510(k) number | 2021-03-25 | Class II | Vendor change control | Products distributed as sterile may not have been adequately sterilized | 2023-03-20 | |
| Zavation | 510(k) number | 2021-03-25 | Class II | Vendor change control | Products distributed as sterile may not have been adequately sterilized | 2023-03-20 | |
| Zavation | 510(k) number | 2021-03-25 | Class II | Vendor change control | Products distributed as sterile may not have been adequately sterilized | 2023-03-20 | |
| Zavation | 510(k) number | 2021-03-25 | Class II | Vendor change control | Products distributed as sterile may not have been adequately sterilized | 2023-03-20 | |
| Zavation | 510(k) number | 2021-03-25 | Class II | Vendor change control | Products distributed as sterile may not have been adequately sterilized | 2023-03-20 | |
| Zavation | 510(k) number | 2021-03-25 | Class II | Vendor change control | Products distributed as sterile may not have been adequately sterilized | 2023-03-20 |
Recalls
20 of these are 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 | Closed |
|---|---|---|---|---|---|
| 2021-03-25 | Class II | Vendor change control | Products distributed as sterile may not have been adequately sterilized | 79 units | 2023-03-20 |
| 2021-03-25 | Class II | Vendor change control | Products distributed as sterile may not have been adequately sterilized | 122 units | 2023-03-20 |
| 2021-03-25 | Class II | Vendor change control | Products distributed as sterile may not have been adequately sterilized | 119 units | 2023-03-20 |
| 2021-03-25 | Class II | Vendor change control | Products distributed as sterile may not have been adequately sterilized | 2023-03-20 | |
| 2021-03-25 | Class II | Vendor change control | Products distributed as sterile may not have been adequately sterilized | 56 units | 2023-03-20 |
| 2021-03-25 | Class II | Vendor change control | Products distributed as sterile may not have been adequately sterilized | 10 units | 2023-03-20 |
| 2021-03-25 | Class II | Vendor change control | Products distributed as sterile may not have been adequately sterilized | 130 units | 2023-03-20 |
| 2021-03-25 | Class II | Vendor change control | Products distributed as sterile may not have been adequately sterilized | 200 units | 2023-03-20 |
| 2021-03-25 | Class II | Vendor change control | Products distributed as sterile may not have been adequately sterilized | 503 units | 2023-03-20 |
| 2021-03-25 | Class II | Vendor change control | Products distributed as sterile may not have been adequately sterilized | 2023-03-20 | |
| 2021-03-25 | Class II | Vendor change control | Products distributed as sterile may not have been adequately sterilized | 2 units | 2023-03-20 |
| 2021-03-25 | Class II | Vendor change control | Products distributed as sterile may not have been adequately sterilized | 7 units | 2023-03-20 |
| 2021-03-25 | Class II | Vendor change control | Products distributed as sterile may not have been adequately sterilized | 89 units | 2023-03-20 |
| 2021-03-25 | Class II | Vendor change control | Products distributed as sterile may not have been adequately sterilized | 7 units | 2023-03-20 |
| 2021-03-25 | Class II | Vendor change control | Products distributed as sterile may not have been adequately sterilized | 24 units | 2023-03-20 |
| 2021-03-25 | Class II | Vendor change control | Products distributed as sterile may not have been adequately sterilized | 302 units | 2023-03-20 |
| 2021-03-25 | Class II | Vendor change control | Products distributed as sterile may not have been adequately sterilized | 2023-03-20 | |
| 2021-03-25 | Class II | Vendor change control | Products distributed as sterile may not have been adequately sterilized | 24 units | 2023-03-20 |
| 2021-03-25 | Class II | Vendor change control | Products distributed as sterile may not have been adequately sterilized | 49 units | 2023-03-20 |
| 2021-03-25 | Class II | Vendor change control | Products distributed as sterile may not have been adequately sterilized | 178 units | 2023-03-20 |
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.