FDA device listing
Pine Tree Orthopedic AFO
FDA device listing 1580905951 · Pine Tree Orthopedic Lab, Inc.
Key facts
| Proprietary names | Pine Tree Orthopedic AFO |
|---|---|
| Owner/operator | Pine Tree Orthopedic Lab, Inc. |
| Owner/operator number | 10079791 |
| Product codes | OHI |
| Device names | OHI - Orthosis, Foot Drop |
| Device class | Class I |
| Classification regulations (21 CFR) | 890.3475 |
| Review panels | Physical Medicine |
| Registered establishments | PINE TREE ORTHOPEDIC LAB, INC. |
| Establishment registrations | 3006196605 |
| FEI numbers | 3006196605 |
| Establishment operations | Contract Manufacturer, Manufacturer, 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