FDA device listing
DynAFO Ankle Foot Orthosis,Maramed,Maramed Orthopedic Systems,Miami Fracture Brace,Sky Medical Solid Ankle Foot…
FDA device listing 1351639688 · BioSculptor Corporation
Key facts
| Proprietary names | DynAFO Ankle Foot Orthosis,Maramed,Maramed Orthopedic Systems,Miami Fracture Brace,Sky Medical Solid Ankle Foot Orthosis, SAFO |
|---|---|
| Owner/operator | BioSculptor Corporation |
| Owner/operator number | 10028416 |
| Product codes | ITW |
| Device names | ITW - Joint, Ankle, External Brace |
| Device class | Class I |
| Classification regulations (21 CFR) | 890.3475 |
| Review panels | Physical Medicine |
| Registered establishments | BIOSCULPTOR CORPORATION |
| Establishment registrations | 1000560772 |
| FEI numbers | 1000560772 |
| Establishment operations | Contract Manufacturer, 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