FDA device listing
Joint, Ankle, External Brace - DeRoyal
FDA device listing 1021281598 · DEROYAL INDUSTRIES, INC.
Key facts
| Proprietary names | Joint, Ankle, External Brace - DeRoyal |
|---|---|
| Owner/operator | DEROYAL INDUSTRIES, INC. |
| Owner/operator number | 1044833 |
| 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 | DeRoyal Industries, Inc., DEROYAL INDUSTRIES, INC., DEROYAL INTERCONTINENTAL, S.R.L., Guatemala Medical Manufacturing, Ortho and Surgical Products Enterprises S.A. |
| Establishment registrations | 1034876, 1043214, 1060680, 3004605321, 3010452421, 3045857302 |
| FEI numbers | 1034876, 1043214, 1000208624, 3004605321, 3010452421, 3045857302 |
| Establishment operations | Complaint File Establishment, Specification Developer, Contract Manufacturer, 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