Balloon Inflation Devices
The product is intended to be used by medical institutions mainly for pressurizing the balloon dilatation catheters by injecting a contrast agent to inflate the inflatable component during…
The product is intended to be used by medical institutions mainly for pressurizing the balloon dilatation catheters by injecting a contrast agent to inflate the inflatable component during minimally invasive orthopedic surgeries.
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 | Shanghai Lange Medtech Co., Ltd., China |
|---|---|
| FDA product code | OCJ |
| Device type | Spinal Channeling Instrument, Vertebroplasty |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2026-06-18 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| S06-30 | 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 |
| Kyphoplasty Tool Kit | Jiangsu Changmei Medtech Co., Ltd. | 2 |
| Kiva | Benvenue Medical, Inc. | 2 |
| Vertebroplasty needles | Teknimed SAS | 2 |
| Aliquot | Stryker GmbH | 2 |
| Blazer | Benvenue Medical, Inc. | 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.