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

• 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

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[G28440901]

Moist Heat or Steam Sterilization

[G28440901]

Moist Heat or Steam Sterilization

[G28440901]

Moist Heat or Steam Sterilization

[G28440901]

Moist Heat or Steam Sterilization

[G28440901]

Moist Heat or Steam Sterilization

[G28440901]

Moist Heat or Steam Sterilization

[G28440901]

Moist Heat or Steam Sterilization

[G28440901]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-06-29
• Device Publish Date: 2022-06-21

On-Brand Devices [KTC Burr Hole Cover]

• G28441001: The NeuroVention Cranial Fixation System is intended for use as a burr hole cover and/or skull b
• G28440901: The NeuroVention Cranial Fixation System is intended for use as a burr hole cover and/or skull b