KTC Burr Hole Cover

FDA UDI

Class II (US FDA UDI)

by Neurovention LLC

Identity

Trade Name: KTC Burr Hole Cover FDA UDI
Generic Name: Cranioplasty plate, alterable FDA UDI
Device Name: 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 3-piece plate is made from PEEK. FDA UDI
Model / Reference: 410-01 FDA UDI
Description: 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 3-piece plate is made from PEEK. FDA UDI

Identifiers

Primary DI / UDI-DI: G28441001 FDA UDI
510(k) Number: K192162 FDA UDI
FDA Product Code: GXR FDA UDI
GWO FDA UDI
GMDN Term: Cranioplasty plate, alterable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.5250 FDA UDI
882.5320 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Cranioplasty plate, alterable

KTC Burr Hole Cover by Neurovention LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cranioplasty plate, alterable.

OsteoMed — Osteomed Corp. · Class II
Innovasis® Cranial System — Innovasis, Inc. · Class II
Innovasis® Cranial System — Innovasis, Inc. · Class II
Neuro & Craniofacial Fixation System — Innovasis, Inc. · Class II
OsteoMed — Osteomed Corp. · Class II
"1.5MM" SYSTEM PLATE — BIOMET MICROFIXATION, INC · Class II
Neuro & Craniofacial Fixation System — Innovasis, Inc. · Class II
Leforte Neuro System Bone Plate — Jeil Medical Corporation · Class II

Cleared under the same submission

K192162 also covers:

Drill Bit — Neurovention LLC
KTC Burr Hole Cover — Neurovention LLC
NuCrani Large Plate — Neurovention LLC
NuCrani Small Plate — Neurovention LLC
Rescue Screw Torx Slot — Neurovention LLC
Screw T6 Torx — Neurovention LLC
Screw Torx Slot — Neurovention LLC
Screw Torx Slot — Neurovention LLC

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Neurovention LLC

Sources (1)

FDA UDI 6e16b093-ba85-4a7c-b9a7-0741745aeb57 34 fields · synced May 30, 2026