FDA device listing
Curve Navigation,Curve Navigation 17700,Disposable Skull Reference Bone Fixation Screw 1.5 mm x 6 mm,Disposable Skull…
FDA device listing 1817638413 · Brainlab SE
Key facts
| Proprietary names | Curve Navigation,Curve Navigation 17700,Disposable Skull Reference Bone Fixation Screw 1.5 mm x 6 mm,Disposable Skull Reference Drill Bit 1.1 mm for Bone Fixation Screw,EM Instrument Tracker,EM Patient Reference,EM Pointer,EM Registration Pointer,EM Short Pointer,ENT EM,Kick 2 Navigation Station EM,Skull Reference Base EM |
|---|---|
| Owner/operator | Brainlab SE |
| Owner/operator number | 9004547 |
| Premarket submissions | K223734 |
| Product codes | HAW, PGW |
| Device names | HAW - Neurological Stereotaxic Instrument, PGW - Ear, Nose, And Throat Stereotaxic Instrument |
| Device class | Class II |
| Classification regulations (21 CFR) | 882.4560 |
| Review panels | Neurology |
| Registered establishments | BRAINLAB SE |
| Establishment registrations | 8043933 |
| FEI numbers | 3002619595 |
| Establishment operations | 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