FDA device listing
BIOMET GENERAL,MANUAL INSTRUMENT,ORTHOPEDIC,ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
FDA device listing 1718490790 · Zimmer Inc
Key facts
| Proprietary names | BIOMET GENERAL,MANUAL INSTRUMENT,ORTHOPEDIC,ORTHOPEDIC MANUAL SURGICAL INSTRUMENT |
|---|---|
| Owner/operator | Zimmer Inc |
| Owner/operator number | 1825034 |
| 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 | BIOMET FRANCE, BIOMET, INC., BIOMET UK LTD., Zhejiang Biomet Medical Products Co., Ltd. |
| Establishment registrations | 1825034, 3002806535, 3006801265, 3006946279 |
| FEI numbers | 1825034, 3002806535, 3006801265, 3006946279 |
| Establishment operations | Contract Manufacturer, Manufacturer, 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