FDA device listing
NEURO ACTIVE (system joint),NEURO ACTIVE (system side bar),NEURO CLASSIC,NEURO CLASSIC Carbon,NEURO CLASSIC zero,NEURO…
FDA device listing 1648266616 · Fior & Gentz Gesellschaft fuer Entwicklung und Vertrieb von
Key facts
| Proprietary names | NEURO ACTIVE (system joint),NEURO ACTIVE (system side bar),NEURO CLASSIC,NEURO CLASSIC Carbon,NEURO CLASSIC zero,NEURO FLEX MAX (lock function),NEURO FLEX MAX (step lock function),NEURO HiTRONIC,NEURO LOCK,NEURO LOCK Carbon,NEURO LOCK MAX,NEURO MATIC,NEURO TRONIC,NEURO VARIO,NEURO VARIO 2,NEURO VARIO-SWING,NEURO VARIO zero |
|---|---|
| Owner/operator | Fior & Gentz Gesellschaft fuer Entwicklung und Vertrieb von |
| Owner/operator number | 10050337 |
| Product codes | ITQ |
| Device names | ITQ - Joint, Knee, External Brace |
| Device class | Class I |
| Classification regulations (21 CFR) | 890.3475 |
| Review panels | Physical Medicine |
| Registered establishments | FIOR AND GENTZ GMBH |
| Establishment registrations | 3011404939 |
| FEI numbers | 3011404939 |
| Establishment operations | 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