FDA device listing
Altius BC,Altius Cuff Large,Altius Cuff Medium,Altius Cuff Small,Altius IPG,Altius IPG Accessory Kit,Altius PAPC,Altius…
FDA device listing 2033553852 · Neuros Medical Inc.
Key facts
| Proprietary names | Altius BC,Altius Cuff Large,Altius Cuff Medium,Altius Cuff Small,Altius IPG,Altius IPG Accessory Kit,Altius PAPC,Altius PTC,Altius PW |
|---|---|
| Owner/operator | Neuros Medical Inc. |
| Owner/operator number | 10091346 |
| Premarket submissions | P230020 |
| Product codes | SAZ |
| Device names | SAZ - Stimulator, Nerve Terminus, Totally Implanted For Chronic Intractable Post-Amputation Pain Of The Lower Limb |
| Device class | Class III |
| Classification regulations (21 CFR) | ORCA1.SAZ |
| Review panels | Neurology |
| Registered establishments | NEUROS MEDICAL INC. |
| Establishment registrations | 3026283936 |
| FEI numbers | 3026283936 |
| Establishment operations | Complaint File Establishment, Manufacturer, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 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