FDA device listing
Elastic Thumb Spica,Exoform Carpal Tunnel Wrist,Exoform Wrist,Formfit Pro Wrist,Formfit Thumb,Formfit Universal…
FDA device listing 1472472641 · OSSUR Americas
Key facts
| Proprietary names | Elastic Thumb Spica,Exoform Carpal Tunnel Wrist,Exoform Wrist,Formfit Pro Wrist,Formfit Thumb,Formfit Universal Thumb,Formfit Universal Wrist,Formfit Wrist,Spectra Wrist Brace,Thumb Spica,Universal Thumb Splint,Wrist Brace,Wrist/Thumb Brace |
|---|---|
| Owner/operator | OSSUR Americas |
| Owner/operator number | 9026971 |
| Product codes | ILH |
| Device names | ILH - Splint, Hand, And Components |
| Device class | Class I |
| Classification regulations (21 CFR) | 890.3475 |
| Review panels | Physical Medicine |
| Registered establishments | OSSUR AMERICAS, OSSUR EUROPE B.V., Ossur Iceland ehf. |
| Establishment registrations | 2242474, 3003764610, 3004161950 |
| FEI numbers | 2242474, 3003764610, 3004161950 |
| Establishment operations | Complaint File Establishment, Specification Developer, Foreign Exporter, Repackager/Relabeler |
| 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