FDA device listing
ITOTAL PATELLA SIZERS,ITOTAL TIBIAL KEEL PUNCH
FDA device listing 1738964230 · American Casting Company
Key facts
| Proprietary names | ITOTAL PATELLA SIZERS,ITOTAL TIBIAL KEEL PUNCH |
|---|---|
| Owner/operator | American Casting Company |
| Owner/operator number | 10045939 |
| 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 | American Casting Company |
| Establishment registrations | 3009628349 |
| FEI numbers | 3009628349 |
| Establishment operations | Contract 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