FDA device listing
Medline UNITE’s REFLEX Hybrid Nitinol Implant System
FDA device listing 2033900228 · Medical Component Specialists
Key facts
| Proprietary names | Medline UNITE’s REFLEX Hybrid Nitinol Implant System |
|---|---|
| Owner/operator | Medical Component Specialists |
| Owner/operator number | 10053311 |
| 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 | MEDICAL COMPONENT SPECIALISTS |
| Establishment registrations | 3011874600 |
| FEI numbers | 3011874600 |
| 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