FDA device listing
0 Deg Capt/Uncapt Cutting Head,3 Deg Capt/Uncapt Cutting Head,Distal Femoral Resection Guide,Drill Guide,Fem Cut…
FDA device listing 1429579418 · LH Medical Corporation
Key facts
| Proprietary names | 0 Deg Capt/Uncapt Cutting Head,3 Deg Capt/Uncapt Cutting Head,Distal Femoral Resection Guide,Drill Guide,Fem Cut Guide,Femoral Valgus Alignment Guide,LCCK 6 Deg Dist Fem Gde,Mini Im Alignment Guide - Long,Mini Im Alignment Guide - Short,Nexgen Pat Drill Gde Sz26 29mm,Nexgen Pat Drill Gde Sz32 35mm,Nexgen Pat Drill Gde Sz38 41mm,PFJ Milling Guide,Rev Block Cutter 5, 10, 15, 20,RH Knee Condylar… |
|---|---|
| Owner/operator | LH Medical Corporation |
| Owner/operator number | 10042802 |
| Product codes | FZX |
| Device names | FZX - Guide, Surgical, Instrument |
| Device class | Class I |
| Classification regulations (21 CFR) | 878.4800 |
| Review panels | General & Plastic Surgery |
| Registered establishments | LH MEDICAL CORPORATION |
| Establishment registrations | 3010057495 |
| FEI numbers | 3010057495 |
| 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