FDA device listing
Biomass Delivery Curette™,Biomass Delivery Trephine™,System Egret™ Outflow Adapter and Accessories,The Angler 3.5™,The…
FDA device listing 1600552448 · ORTHOPEDIC SCIENCES, INC.
Key facts
| Proprietary names | Biomass Delivery Curette™,Biomass Delivery Trephine™,System Egret™ Outflow Adapter and Accessories,The Angler 3.5™,The Angler 4.5L™,The Angler 4.5S™,The Red Belly 3.5™,The Red Belly 4.5L™,The Red Belly 4.5S™ |
|---|---|
| Owner/operator | ORTHOPEDIC SCIENCES, INC. |
| Owner/operator number | 9051896 |
| Product codes | HTF |
| Device names | HTF - Curette |
| Device class | Class I |
| Classification regulations (21 CFR) | 878.4800 |
| Review panels | General & Plastic Surgery |
| Registered establishments | ORTHOPEDIC SCIENCES, INC |
| Establishment registrations | 2032830 |
| FEI numbers | 3004167986 |
| Establishment operations | Specification Developer |
| 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