NeuroVention Cranial Fixation System, NuCrani Plates, KTC Burr Hole Cover, DC Plate
NeuroVention LLC
NEUROVENTION, LLC
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3017884860 | 3017884860 | NEUROVENTION, LLC | 1 | N | 2026-01-01 | 645 S. Beach St Daytona Beach FL US 32114 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 286301 | 1320989012 | K192162 | NeuroVention Cranial Fixation System, NuCrani Plates, KTC Burr Hole Cover, DC Plate | GXR | 2020-03-13 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| GXR | 1 | 2020-03-13 |
PMN#
NEURO VENTION LAMINPLASTY PLATING SYSTEM
NEUROVENTION LLC
GUDID#
Screw T6 Torx - Screw T6 Torx 2mm X 5mm Model Number 241-04BScrew T6 Torx 2mm X 6mm Model Number 241-04C
2025-05-12
Screwdriver Bit Torx - Screwdriver Bit Torx6, Single Use
2025-05-12
Drill Bit - Drill Bit 1.7 mm, Single-Use
2024-10-17
Screw Torx Slot - Screw Torx Slot 2mm x 6 mm
2022-09-09
Screw Torx Slot - 2mm x 6 mm
2022-06-21
Rescue Screw Torx Slot - 2.3 mm x 6 mm
2022-06-21
Tray - Instrument and Device Tray. Includes parts NN-01-CD-01 Caddy, NN-01-CD-02 Caddy Lid, NN-01-CS Implant and Caddy Sterilization Tray, and NN-01-CV Tray Lid
2022-06-21
Screwdriver Bit Torx Slot - Screwdriver Bit Torx Slot, Single Use
2022-06-22
NuCrani Small Plate - The NeuroVention Cranial Fixation System is intended for use as a burr hole cover and/or skull bone fixation followingcraniotomy, cranioplasty, or craniectomy surgery.
2022-06-21
Screwdriver Bit Torx - Screwdriver Bit T4 Torx, Single Use
2022-06-21
Drill Bit - Drill Bit, 1.5 mm x 6 mmm, Single Use
2022-06-21
Screwdriver - 353-01
2022-06-21
NuCrani Large Plate - The NeuroVention Cranial Fixation System is intended for use as a burr hole cover and/or skull bone fixation followingcraniotomy, cranioplasty, or craniectomy surgery.
2022-06-21
Screwdriver Spanner - Screwdriver Spanner Slot Driver Bit, Single Use
2022-06-21
KTC Burr Hole Cover - The NeuroVention Cranial Fixation System is intended for use as a burr hole cover and/or skull bone fixation following craniotomy, cranioplasty, or craniectomy surgery. KTC 2-piece plate is made from PEEK .
2022-06-21
KTC Burr Hole Cover - The NeuroVention Cranial Fixation System is intended for use as a burr hole cover and/or skull bone fixation followingcraniotomy, cranioplasty, or craniectomy surgery. KTC 3-piece plate is made from PEEK.
2022-06-21