# K192162: NeuroVention Cranial Fixation System, NuCrani Plates, KTC Burr Hole Cover, DC Plate

- Pathway: 510(k) (Traditional)
- Applicant: Neurovention, LLC
- Decided: Mar 13, 2020 after 217 days
- Product code: GXR (Cover, Burr Hole)
- Device class: 2
- Regulation: 21 CFR 882.5250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K761228 (1976). 30 ancestors in all.
No later device cites it as a predicate yet.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112557: Stryker Universal Neuro 3 System, Stryker (2012) Summary page 4.

## Indications for use
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.

Source page: https://510kreport.com/device/K192162
Methodology: https://510kreport.com/methodology