Data / Medical devices / United States / Neurovention, LLC
Neurovention, LLC: FDA-registered device maker in Daytona Beach, FL, United States, 1 510(k) clearance
Neurovention, LLC is registered with the FDA (registration 3017884860) in Daytona Beach, FL, United States. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated March 13, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3017884860
- Address
- 645 S. Beach St, Daytona Beach, FL, United States, 32114
- Owner or operator
- NeuroVention, LLC (10080022)
- Roles
- Specification developer
- First device listed
- January 7, 2021
- Registered through
- 2026
- Brand names listed
- DC Plate, Drill bit, Driver bit Torx, Driver bit Torx Slot, KTC Burr Hole Cover, NuCrani Plates, Rescue Screw Torx Slot, Screw Torx Slot and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cover, Burr Hole | GXR | 2 | Specification developer | accessdata.fda.gov |
| Fastener, Plate, Cranioplasty | HBW | 2 | Specification developer | accessdata.fda.gov |
| Plate, Cranioplasty, Preformed, Alterable | GWO | 2 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 13, 2020 | K192162 | NeuroVention Cranial Fixation System, NuCrani Plates, KTC Burr Hole Cover, DC Plate | GXR | Substantially Equivalent | Neurovention, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Plate, Cranioplasty, Preformed, Alterable
- All makers of Cover, Burr Hole
- All makers of Fastener, Plate, Cranioplasty
Updated March 13, 2020. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.