FDA device listing
SterraMed Adjustable Angle Guide,SterraMed AMP Head Gauge, 37 to 53 mm,SterraMed Bone Cutter Double Action, Curved, 6…
FDA device listing 1732857608 · Sterramed Inc
Key facts
| Proprietary names | SterraMed Adjustable Angle Guide,SterraMed AMP Head Gauge, 37 to 53 mm,SterraMed Bone Cutter Double Action, Curved, 6 inch,SterraMed Bone Cutter Double Action, Curved, 7.5 inch,SterraMed Bone Cutter Double Action, Curved, 9 inch,SterraMed Bone Cutter Double Action, Straight, 6 inch,SterraMed Bone Cutter Double Action, Straight, 7.5 inch,SterraMed Bone Cutter Double Action, Straight, 9… |
|---|---|
| Owner/operator | Sterramed Inc |
| Owner/operator number | 10094296 |
| Product codes | LXH |
| Device names | LXH - Orthopedic Manual Surgical Instrument |
| Device class | Class I |
| Classification regulations (21 CFR) | 888.4540 |
| Review panels | Orthopedic |
| Registered establishments | STERRAMED INC |
| Establishment registrations | 3042248499 |
| FEI numbers | 3042248499 |
| Establishment operations | Repackager/Relabeler, 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