FDA device listing
CoRoent,Graft Integration,Helix,Leverage,MaXcess,NuVasive,PGI,Triad,VuePoint,X-CORE,XLIF,XLR
FDA device listing 1795881401 · Avalign Delivery Systems Division
Key facts
| Proprietary names | CoRoent,Graft Integration,Helix,Leverage,MaXcess,NuVasive,PGI,Triad,VuePoint,X-CORE,XLIF,XLR |
|---|---|
| Owner/operator | Avalign Delivery Systems Division |
| Owner/operator number | 9026184 |
| Product codes | KCT |
| Device names | KCT - Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Device class | Class II |
| Classification regulations (21 CFR) | 880.6850 |
| Review panels | General Hospital |
| Registered establishments | Avalign Delivery Systems Division |
| Establishment registrations | 1835444 |
| FEI numbers | 3000717687 |
| Establishment operations | Contract 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