FDA device listing
LUMIS Cannulated Polyaxial Screw Fixation System,ULIS Polyaxial Screw Fixation System
FDA device listing 1025936632 · SPINEVISION SAS
Key facts
| Proprietary names | LUMIS Cannulated Polyaxial Screw Fixation System,ULIS Polyaxial Screw Fixation System |
|---|---|
| Owner/operator | SPINEVISION SAS |
| Owner/operator number | 9048013 |
| Premarket submissions | K112607 |
| Product codes | KWP, KWQ, MNH, MNI, NKB |
| Device names | KWP - Appliance, Fixation, Spinal Interlaminal, KWQ - Appliance, Fixation, Spinal Intervertebral Body, MNH - Orthosis, Spondylolisthesis Spinal Fixation, MNI - Orthosis, Spinal Pedicle Fixation, NKB - Thoracolumbosacral Pedicle Screw System |
| Device class | Class II |
| Classification regulations (21 CFR) | 888.3050, 888.3060, 888.3070 |
| 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
- 10–99 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