AutoPlex, VertaPlex
System with Needle and Bone Cement
5manufacturers in China registered for this device type
1catalogue number
2recalls on this code
Who Else Makes It
Concentrated in Shanghai (2), Beijing (1), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jiangsu Changmei Medtech Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 8 |
| Beijing Fule Science & Technology Development Co., Ltd. | Beijing | Beijing | Manufacturer | 31 |
| Shanghai Reach Medical Instrument Co., Ltd. | Shanghai | Shanghai | Manufacturer | 30 |
| Shanghai Lange Medtech Co., Ltd. | Shanghai | Shanghai | Manufacturer | 16 |
| Ningbo Hicren Biotechnology Co., Ltd. | Ningbo | Zhejiang | Manufacturer | 5 |
Record
| Listed by | Stryker GmbH, Switzerland |
|---|---|
| FDA product code | OAR |
| Device type | Injector, Vertebroplasty (Does Not Contain Cement) |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4200 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| Record published | 2016-09-23 |
| Record revised | 2021-11-18 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment humidity 10 to 75 % RH; Storage environment temperature -20 to 40 °C; Storage environment atmospheric pressure 50 to 106 KiloPascal |
| Packaging | Pack of 2 |
| Sizes | Length 5 in; needle gauge 11 G |
| Distribution end date | 2021-07-08 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 0605683000 | Length 5.0 in | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Biopsybell | Biopsybell SRL | 18 |
| Medinaut-V | Imedicom Co., Ltd. | 16 |
| Injector, Vertebroplasty (Does Not Contain Cement) | Stryker GmbH | 14 |
| KMC Bone Cement Delivery System | Shanghai KiNETIC Medical Co Ltd | 9 |
| K2M Fenestrated Tap System | VB Spine LLC | 7 |
| iVAS | Stryker GmbH | 7 |
| VertePort X4 Manifold | Stryker GmbH | 6 |
| Aliquot | Stryker GmbH | 5 |
| Dfine® | Merit Medical Systems, Inc. | 5 |
| IM Nail Dispenser Mold | Bonesetter Holdings, LLC | 4 |
| Synject | Synthes Gmbh | 4 |
| VertePort | Stryker GmbH | 4 |
Showing 12 of 50. All products under Injector, Vertebroplasty (Does Not Contain Cement)
Recalls
2 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 |
|---|---|---|---|---|---|
| 2017-11-09 | Class II | Environmental control | Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates. | 900 | 2019-04-16 |
| 2017-11-09 | Class II | Environmental control | Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates. | 12 | 2019-04-16 |
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.