FDA device listing
Baseball finger splint,Base Ball Splint,Cot Finger splint,Cot Splint,Frog Splint,Frog type Finger splint,Spoon finger…
FDA device listing 1059545498 · SPM MEDICARE PVT, LTD.
Key facts
| Proprietary names | Baseball finger splint,Base Ball Splint,Cot Finger splint,Cot Splint,Frog Splint,Frog type Finger splint,Spoon finger splint,Spoon Splint,TRUSTMED Ortho,TRUSTMED Ortho Base Ball Splint,TRUSTMED Ortho Cot Splint,TRUSTMED Ortho Frog Splint,TRUSTMED Ortho Spoon Splint |
|---|---|
| Owner/operator | SPM MEDICARE PVT, LTD. |
| Owner/operator number | 10088418 |
| Product codes | LZB |
| Device names | LZB - Finger Cot |
| Device class | Class I |
| Classification regulations (21 CFR) | 880.6250 |
| Review panels | General Hospital |
| Registered establishments | SPM MEDICARE PVT, LTD. |
| Establishment registrations | 3016707060 |
| FEI numbers | 3016707060 |
| Establishment operations | 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