FDA device listing
DIXI Medical Adapter,DIXI Medical Anchor Bolt,DIXI Medical Bone Starter,DIXI Medical Cap for Anchor Bolt,DIXI Medical…
FDA device listing 1004581481 · DIXI Medical
Key facts
| Proprietary names | DIXI Medical Adapter,DIXI Medical Anchor Bolt,DIXI Medical Bone Starter,DIXI Medical Cap for Anchor Bolt,DIXI Medical Coagulation Electrode and Stop,DIXI Medical Connection Cable,DIXI Medical Depth Report Device,DIXI Medical Drill and Stop,DIXI Medical Extension Cable,DIXI Medical Flat Screwdriver,DIXI Medical Instrument Guide,DIXI Medical Long Screwdriver,DIXI Medical Marking Rod,DIXI Medical… |
|---|---|
| Owner/operator | DIXI Medical |
| Owner/operator number | 10056327 |
| Premarket submissions | K170959 |
| Product codes | GZL |
| Device names | GZL - Electrode, Depth |
| Device class | Class II |
| Classification regulations (21 CFR) | 882.1330 |
| Review panels | Neurology |
| Registered establishments | DIXI MEDICAL |
| Establishment registrations | 3007636029 |
| FEI numbers | 3007636029 |
| Establishment operations | Complaint File Establishment, Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 10–99 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes 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