FDA device listing
Miami TLSO 456,Miami TLSO 464
FDA device listing 1220118736 · OSSUR Americas
Key facts
| Proprietary names | Miami TLSO 456,Miami TLSO 464 |
|---|---|
| Owner/operator | OSSUR Americas |
| Owner/operator number | 9026971 |
| Product codes | IPT |
| Device names | IPT - Orthosis, Thoracic |
| Device class | Class I |
| Classification regulations (21 CFR) | 890.3490 |
| Review panels | Physical Medicine |
| Registered establishments | OSSUR EUROPE B.V., Ossur Iceland ehf., Ossur Mexico |
| Establishment registrations | 3003764610, 3004161950, 3008523132 |
| FEI numbers | 3003764610, 3004161950, 3008523132 |
| Establishment operations | Complaint File Establishment, Specification Developer, Contract Manufacturer, Foreign Exporter |
| 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