K2M Fenestrated Tap System
Tap, Fenestrated, Size Ø4.5 mm
5manufacturers in China registered for this device type
7catalogue 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 | VB Spine LLC |
|---|---|
| FDA product code | OAR |
| Device type | Injector, Vertebroplasty (Does Not Contain Cement) |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4200 |
| Record published | 2021-08-06 |
| Record revised | 2026-04-20 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Sizes | Outer diameter 4.5 to 6.5 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PRO-1117-02 | Outer Diameter 4.5 mm | In distribution |
| PRO-1117-03 | Outer Diameter 5.5 mm | In distribution |
| 5001-90013 | In distribution | |
| SP-4029-04 | Outer Diameter 6.5 mm | In distribution |
| PRO-1117-04 | Outer Diameter 6.5 mm | In distribution |
| 5001-90016 | In distribution | |
| SP-4029-02 | Outer Diameter 4.5 mm | 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 |
| KMC Bone Cement Delivery System | Shanghai KiNETIC Medical Co Ltd | 9 |
| 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.