FDA device listing
Dymaxeon Spine System
FDA device listing 1462576624 · Signature Orthopaedics Pty Limited
Key facts
| Proprietary names | Dymaxeon Spine System |
|---|---|
| Owner/operator | Signature Orthopaedics Pty Limited |
| Owner/operator number | 10037793 |
| Product codes | MNH, MNI, NKB |
| Device names | MNH - Orthosis, Spondylolisthesis Spinal Fixation, MNI - Orthosis, Spinal Pedicle Fixation, NKB - Thoracolumbosacral Pedicle Screw System |
| Device class | Class II |
| Classification regulations (21 CFR) | 888.3070 |
| Review panels | Orthopedic |
| Registered establishments | Signature Orthopaedics Europe Ltd, SIGNATURE ORTHOPAEDICS PTY LIMITED |
| Establishment registrations | 3008262872, 3014763043 |
| FEI numbers | 3008262872, 3014763043 |
| 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