FDA.reportPublic FDA data

KTC Burr Hole Cover

Primary DI
G28441001
Brand
KTC Burr Hole Cover
Company
Neurovention LLC
Model
410-01
Device description
The NeuroVention Cranial Fixation System is intended for use as a burr hole cover and/or skull bone fixation followingcraniotomy, cranioplasty, or craniectomy surgery. KTC 3-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
G28441001PrimaryHIBCC0

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
G28440901KTC Burr Hole Cover409-012022-06-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08806390889049Leforte Neuro System Bone PlateJeil Medical CorporationGXR2023-11-30
08806390889049Leforte Neuro System Bone PlateJeil Medical CorporationGWO2023-11-30
G28436102NuCrani Large PlateNeurovention LLCGXR2022-06-21
G28440901KTC Burr Hole CoverNeurovention LLCGWO2022-06-21
08806390888851Leforte Neuro System Bone PlateJeil Medical CorporationGWO2022-05-03
08806390888851Leforte Neuro System Bone PlateJeil Medical CorporationGXR2022-05-03
07613327543032DELTAStryker Leibinger GmbH & Co. KGGXR2020-12-15
07613327423648DELTAStryker Leibinger GmbH & Co. KGGXR2018-05-22
07613327423655DELTAStryker Leibinger GmbH & Co. KGGXR2018-05-22
07613327423679DELTAStryker Leibinger GmbH & Co. KGGXR2018-05-22
08806390869539Leforte Neuro System Bone PlateJeil Medical CorporationGXR2018-05-17
08806390869546Leforte Neuro System Bone PlateJeil Medical CorporationGXR2018-05-17
08806390869553Leforte Neuro System Bone PlateJeil Medical CorporationGXR2018-05-17
08806390869560Leforte Neuro System Bone PlateJeil Medical CorporationGXR2018-05-17
08806390869577Leforte Neuro System Bone PlateJeil Medical CorporationGXR2018-05-17
07613327177527DELTAStryker Leibinger GmbH & Co. KGGXR2018-04-16
07613327177534DELTAStryker Leibinger GmbH & Co. KGGXR2018-04-16
08809265151982Leforte Neuro System Bone PlateJeil Medical CorporationGWO2018-04-12
08809265151982Leforte Neuro System Bone PlateJeil Medical CorporationGXR2018-04-12
08806390862271Leforte Neuro System Bone PlateJeil Medical CorporationGXR2018-02-26
08806390862271Leforte Neuro System Bone PlateJeil Medical CorporationGWO2018-02-26
08806390861953Leforte Neuro System Bone PlateJeil Medical CorporationGXR2018-01-22
08806390861953Leforte Neuro System Bone PlateJeil Medical CorporationGWO2018-01-22
07613327400953DELTAStryker Leibinger GmbH & Co. KGGXR2017-12-05
08806390855150Sterile NS SystemJeil Medical CorporationGXR2017-10-13
08806390855167Sterile NS SystemJeil Medical CorporationGXR2017-10-13
08806390855167Sterile NS SystemJeil Medical CorporationGWO2017-10-13
08806390855174Sterile NS SystemJeil Medical CorporationGXR2017-10-13
08806390855181Sterile NS SystemJeil Medical CorporationGXR2017-10-13
08806390855181Sterile NS SystemJeil Medical CorporationGWO2017-10-13