Biopsybell
Device for cement infusion in the vertebroplasty/kyphoplasty procedure
5manufacturers in China registered for this device type
18catalogue numbers in this listing
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 | Biopsybell SRL |
|---|---|
| FDA product code | OAR |
| Device type | Injector, Vertebroplasty (Does Not Contain Cement) |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4200 |
| Premarket notification | Exempt |
| Record published | 2022-09-19 |
| Record revised | 2025-03-14 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Storage | Handling environment temperature 5 to 40 °C |
| Packaging | Pouch of 2, pouch of 10, box of 10, blister of 10 |
| Sizes | Needle gauge 8 to 16 G; length 35 to 250 mm; outer diameter 2.3 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SCREWFIX | Needle Gauge 16 G | In distribution |
| SCREWFIX | Needle Gauge 16 G | In distribution |
| VERTEBROSTEEL | Needle Gauge 11 G | In distribution |
| VERTEBROPLASTY EXTENTION LINES | In distribution | |
| VERTEBROPLASTY SYRINGES | In distribution | |
| EASYNJECT | In distribution | |
| SCREWFIX | Needle Gauge 16 G | In distribution |
| SCREWFIX | Needle Gauge 16 G | In distribution |
| KYPHOKIT BONE FILLER | Needle Gauge 11 G | In distribution |
| EASYNJECT “S” | In distribution | |
| RENOVA SPINE BONE FILLER | Needle Gauge 11 G | In distribution |
| RENOVA SPINE BONE FILLER | Needle Gauge 08 G | In distribution |
| RENOVA SPINE BONE FILLER | Needle Gauge 10 G | In distribution |
| SCREWFIX | Needle Gauge 16 G | In distribution |
| V-STRUT BONE FILLER | Outer Diameter 2.30 mm | In distribution |
| CIFOPACK BONE FILLER | Needle Gauge 11 G | In distribution |
| VERTEBROPLASTIC | Needle Gauge 11 G | In distribution |
| EASYNJECT | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| PCD | Stryker GmbH | 3 |
Showing 12 of 50. All products under Injector, Vertebroplasty (Does Not Contain Cement)
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.