Kyphoplasty Tool Kit
Kyphoplasty Tool Kit (Bilateral standard type)
5manufacturers in China registered for this device type
2catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (2), Beijing (1), Jiangsu (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Beijing Fule Science & Technology Development Co., Ltd. | Beijing | Beijing | Manufacturer | 31 |
| Shanghai Lange Medtech Co., Ltd. | Shanghai | Shanghai | Manufacturer | 16 |
| Jiangsu Changmei Medtech Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 8 |
| Ningbo Hicren Biotechnology Co., Ltd. | Ningbo | Zhejiang | Manufacturer | 5 |
Record
| Listed by | Jiangsu Changmei Medtech Co., Ltd., China |
|---|---|
| FDA product code | OCJ |
| Device type | Spinal Channeling Instrument, Vertebroplasty |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Establishment | Contract manufacturer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2025-10-23 |
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 up to 80 % RH |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| KT-00-06 | In distribution | |
| KT-00-05 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Biopsybell | Biopsybell SRL | 25 |
| Biopsybell SRL | Biopsybell SRL | 9 |
| V-Access | G21 SRL | 6 |
| Capo Needle | Nexone BIO Co., Ltd. | 5 |
| Spinal Channeling Instrument, Vertebroplasty | Stryker GmbH | 3 |
| Bone Drills | Shanghai Lange Medtech Co., Ltd. | 2 |
| KeyFix Direct Access Needle | G21 SRL | 2 |
| Kiva | Benvenue Medical, Inc. | 2 |
| Vertebroplasty needles | Teknimed SAS | 2 |
| Aliquot | Stryker GmbH | 2 |
| Blazer | Benvenue Medical, Inc. | 2 |
| Main-AXS Needle-Spinal Simplicity | Mainstream Medical Devices | 2 |
Showing 12 of 33. All products under Spinal Channeling Instrument, Vertebroplasty
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.