FDA device listing
Kyphoplasty Tool Kit
FDA device listing 1853639018 · Jiangsu Changmei Medtech Co.,Ltd
Key facts
| Proprietary names | Kyphoplasty Tool Kit |
|---|---|
| Owner/operator | Jiangsu Changmei Medtech Co.,Ltd |
| Owner/operator number | 10065161 |
| Product codes | OAR |
| Device names | OAR - Injector, Vertebroplasty (Does Not Contain Cement) |
| Device class | Class I |
| Classification regulations (21 CFR) | 888.4200 |
| Review panels | Orthopedic |
| Registered establishments | JIANGSU CHANGMEI MEDTECH CO.,LTD |
| Establishment registrations | 3016789487 |
| FEI numbers | 3016789487 |
| Establishment operations | Complaint File Establishment, Contract Manufacturer, Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database