FDA.reportPublic FDA data

KTC Burr Hole Cover

Primary DI
G28440901
Brand
KTC Burr Hole Cover
Company
Neurovention LLC
Model
409-01
Device 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 2-piece plate is made from PEEK .
Published
2022-06-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
GWOPlate, Cranioplasty, Preformed, Alterable
GXRCover, Burr Hole

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWOPlate, Cranioplasty, Preformed, AlterableNeurology2
GXRCover, Burr HoleNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K192162000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192162000NeuroVention Cranial Fixation System, NuCrani Plates, KTC Burr Hole Cover, DC PlateNeurovention, LLC2020-03-13GXR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G28440901PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Cranioplasty plate, alterableAn implantable shield designed to repair larger skull defects that is preformed before surgery and typically made of sheets of material (e.g., tantalum) that can be reshaped at the time of surgery without changing the physical or chemical properties of the material. The device is generally preformed with a central convex curvature matching the curvature of the forehead, side, or rear areas of the human adult skull; it is usually fixed to the intact cranial bones using screws and/or other fasteners. The device is used to repair defects due to injury, surgical intervention for tumour removal, congenital anomaly, or disease.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
074912476
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G28424104Screw T6 Torx241-042025-05-12
G28433305Screwdriver Bit Torx333-052025-05-12
G2843520100Drill Bit352-01-002024-10-17
G284241019Screw Torx Slot241-012022-09-09
G28424101Screw Torx Slot241-012022-06-21
G28435101Rescue Screw Torx Slot351-012022-06-21
G284NN01TrayNN-012022-06-21
G28433302Screwdriver Bit Torx Slot333-022022-06-22
G28433001NuCrani Small Plate330-012022-06-21
G28433301Screwdriver Bit Torx333-012022-06-21
G28435201Drill Bit352-012022-06-21
G28435301Screwdriver353-012022-06-21
G28436102NuCrani Large Plate361-022022-06-21
G28437801Screwdriver Spanner378-012022-06-21
G28441001KTC Burr Hole Cover410-012022-06-21

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Primary DI, Brand, Company table
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07613327694482DELTAStryker Leibinger GmbH & Co. KGGXR2026-07-21
07613327694499DELTAStryker Leibinger GmbH & Co. KGGXR2026-07-21
00810125929892CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-07-13
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