FDA device listing
Orthosis, Spondylolisthesis Spinal Fixation
FDA device listing 1596148293 · Astura Medical
Key facts
| Owner/operator | Astura Medical |
|---|---|
| Owner/operator number | 10051052 |
| Premarket submissions | K153446 |
| Product codes | MNH, MNI, OSH |
| Device names | MNH - Orthosis, Spondylolisthesis Spinal Fixation, MNI - Orthosis, Spinal Pedicle Fixation, OSH - Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis |
| Device class | Class II |
| Classification regulations (21 CFR) | 888.3070 |
| Review panels | Orthopedic |
| Registered establishments | Astura Medical |
| Establishment registrations | 3015941638 |
| FEI numbers | 3011764740 |
| Establishment operations | Complaint File Establishment, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None 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