Injector, Vertebroplasty (Does Not Contain Cement)
Match-Ground Four Facet Tip Introduction Needle with Bevel Stylet
5manufacturers in China registered for this device type
14catalogue numbers in this listing
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 |
| Premarket notification | Exempt |
| Record published | 2018-09-24 |
| Record revised | 2021-10-25 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, serial number |
| Packaging | Pack of 6 |
| Sizes | Needle gauge 10 to 14 G; length 4 to 9 in |
| Distribution end date | 2021-07-08 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 0306134000 | Needle Gauge 13.0 G | In distribution |
| 0306140000 | Length 4.4 in | In distribution |
| 0306110000 | Needle Gauge 11.0 G | In distribution |
| 0306114000 | Length 4.0 in | In distribution |
| 0306190000 | Length 9.0 in | In distribution |
| 0306160000 | Length 5.0 in | In distribution |
| 0306111000 | Length 5.0 in | In distribution |
| 0306650000 | In distribution | |
| 0306131000 | Needle Gauge 13.0 G | In distribution |
| 0306191000 | Length 9.0 in | In distribution |
| 0306150000 | Length 5.0 in | In distribution |
| 0306130000 | Needle Gauge 13.0 G | In distribution |
| 0306100000 | Needle Gauge 10.0 G | Withdrawn |
| 0306101000 | Needle Gauge 10.0 G | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Biopsybell | Biopsybell SRL | 18 |
| Medinaut-V | Imedicom Co., Ltd. | 16 |
| 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 |
| PCD | Stryker GmbH | 3 |
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.