FDA device listing
AC2-CSL05C_Convex Ti SA Cervical Cage,AC2-CSL05L_Lordotic Ti SA Cervical Cage,AC2-CSL06C_Convex Ti SA Cervical…
FDA device listing 1311391409 · SPINEVISION SAS
Key facts
| Proprietary names | AC2-CSL05C_Convex Ti SA Cervical Cage,AC2-CSL05L_Lordotic Ti SA Cervical Cage,AC2-CSL06C_Convex Ti SA Cervical Cage,AC2-CSL06L_Lordotic Ti SA Cervical Cage,AC2-CSL07C_Convex Ti SA Cervical Cage,AC2-CSL07L_Lordotic Ti SA Cervical Cage,AC2-CSL08C_Convex Ti SA Cervical Cage,AC2-CSL08L_Lordotic Ti SA Cervical Cage,AC2-CSL09C_Convex Ti SA Cervical Cage,AC2-CSL09L_Lordotic Ti SA Cervical… |
|---|---|
| Owner/operator | SPINEVISION SAS |
| Owner/operator number | 9048013 |
| Premarket submissions | K193000 |
| Product codes | OVE |
| Device names | OVE - Intervertebral Fusion Device With Integrated Fixation, Cervical |
| Device class | Class II |
| Classification regulations (21 CFR) | 888.3080 |
| Review panels | Orthopedic |
| Registered establishments | SPINEVISION INC., SPINEVISION SAS |
| Establishment registrations | 3003526896, 3025457095 |
| FEI numbers | 3003526896, 3025457095 |
| Establishment operations | Complaint File Establishment, Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 100–999 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes 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