KTC Burr Hole Cover

GUDID G28440901

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 .

Neurovention LLC

Cranioplasty plate, alterable Cranioplasty plate, alterable Cranioplasty plate, alterable Cranioplasty plate, alterable Cranioplasty plate, alterable Cranioplasty plate, alterable Cranioplasty plate, alterable Cranioplasty plate, alterable

Primary Device ID	G28440901
NIH Device Record Key	7f102be6-d1e8-42f5-ba0e-a1fc438aa650
Commercial Distribution Status	In Commercial Distribution
Brand Name	KTC Burr Hole Cover
Version Model Number	409-01
Company DUNS	074912476
Company Name	Neurovention LLC
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	MR Conditional
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	G28440901 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K192162

FDA Product Code

GXR	Cover, Burr Hole