FDA device listing
Artho Power Console,Artho Power Console with Irrigation Pump,D4000A-Drive System with Irrigation,D4000 Drive System
FDA device listing 1421871067 · CONMED CORPORATION
Key facts
| Proprietary names | Artho Power Console,Artho Power Console with Irrigation Pump,D4000A-Drive System with Irrigation,D4000 Drive System |
|---|---|
| Owner/operator | CONMED CORPORATION |
| Owner/operator number | 1317214 |
| Premarket submissions | K130497 |
| Product codes | ERL, GEY, HBC |
| Device names | ERL - Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece, GEY - Motor, Surgical Instrument, Ac-Powered, HBC - Motor, Drill, Electric |
| Device class | Class I, Class II |
| Classification regulations (21 CFR) | 874.4250, 878.4820, 882.4360 |
| Review panels | Ear, Nose, & Throat, General & Plastic Surgery, Neurology |
| Registered establishments | Consolidated Medical Equipment Company, Linvatec Corporation |
| Establishment registrations | 1017294, 3007305485 |
| FEI numbers | 1017294, 3007305485 |
| Establishment operations | Contract Manufacturer, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 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