FDA device listing
SA Cervical,Tesera C/Tesera SC Anterior Cervical Fusion (ACF) System
FDA device listing 1303950633 · Sotera Health LLC
Key facts
| Proprietary names | SA Cervical,Tesera C/Tesera SC Anterior Cervical Fusion (ACF) System |
|---|---|
| Owner/operator | Sotera Health LLC |
| Owner/operator number | 10029425 |
| Product codes | ODP, OVE |
| Device names | ODP - Intervertebral Fusion Device With Bone Graft, Cervical, OVE - Intervertebral Fusion Device With Integrated Fixation, Cervical |
| Device class | Class II |
| Classification regulations (21 CFR) | 888.3080 |
| Review panels | Orthopedic |
| Registered establishments | Sterigenics US LLC, Sterigenics US, LLC |
| Establishment registrations | 1423662, 1526534, 1649518 |
| FEI numbers | 1526534, 3000215273, 3001236277 |
| Establishment operations | Contract Sterilizer |
| 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