KMC Bone Cement Delivery System
9 catalogue numbers from FG8108, listed by Shanghai KiNETIC Medical Co Ltd, China, under Injector, Vertebroplasty (Does Not Contain Cement). 5 manufacturers in China are registered for this product code.
5manufacturers in China registered for this device type
9catalogue 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 | Shanghai KiNETIC Medical Co Ltd, China |
|---|---|
| FDA product code | OAR |
| Device type | Injector, Vertebroplasty (Does Not Contain Cement) |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4200 |
| Establishment | Contract manufacturer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2017-07-20 |
| Record revised | 2018-03-29 (version 2) |
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, manufacturing date |
| Storage | Storage environment temperature 18 to 25 °C; Storage environment humidity up to 80 % RH |
| Sizes | Length 60 cm; pressure 440 psi |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| FG8108 | Length 60 cm | In distribution |
| FG8210 | Length 60 cm | In distribution |
| FG8120 | Length 60 cm | In distribution |
| FG8105 | Length 60 cm | In distribution |
| FG8315 | Length 60 cm | In distribution |
| FG8310 | Length 60 cm | In distribution |
| FG8115 | Length 60 cm | In distribution |
| FG8215 | Length 60 cm | In distribution |
| FG8110 | Length 60 cm | In distribution |
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 |
| 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.