FDA device listing
2Mix Gun,Bone Injection Needles,GUN-01,Kyphoplasty Tool Kit,Mendec Kypho Set Bilateral,Mendec Kypho Set…
FDA device listing 1816381531 · TECRES SPA
Key facts
| Proprietary names | 2Mix Gun,Bone Injection Needles,GUN-01,Kyphoplasty Tool Kit,Mendec Kypho Set Bilateral,Mendec Kypho Set Monolateral,Rally All In One Cement Gun,Xtruder |
|---|---|
| Owner/operator | TECRES SPA |
| Owner/operator number | 9033624 |
| Product codes | KIH |
| Device names | KIH - Dispenser, Cement |
| Device class | Class I |
| Classification regulations (21 CFR) | 888.4200 |
| Review panels | Orthopedic |
| Registered establishments | TECRES SPA |
| Establishment registrations | 9614841 |
| FEI numbers | 3002808402 |
| Establishment operations | Foreign Exporter, 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