FDA device listing
Leg Positioner Disposables,SofCare Heel Care Boot
FDA device listing 1818764156 · STRYKER CORP.
Key facts
| Proprietary names | Leg Positioner Disposables,SofCare Heel Care Boot |
|---|---|
| Owner/operator | STRYKER CORP. |
| Owner/operator number | 1811755 |
| Product codes | FMP |
| Device names | FMP - Protector, Skin Pressure |
| Device class | Class I |
| Classification regulations (21 CFR) | 880.6450 |
| Review panels | General Hospital |
| Registered establishments | MAKO SURGICAL CORP., STRYKER MEDICAL |
| Establishment registrations | 1831750, 3017410889 |
| FEI numbers | 1831750, 3005985723 |
| Establishment operations | Complaint File Establishment, 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