FDA.reportPublic FDA data

Rescue Screw Torx Slot

Primary DI
G28435101
Brand
Rescue Screw Torx Slot
Company
Neurovention LLC
Model
351-01
Device description
2.3 mm x 6 mm
Published
2022-06-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
HBWFastener, Plate, Cranioplasty

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HBWFastener, Plate, CranioplastyNeurology2

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
G28435101PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Cranioplasty plate screwA small, threaded rod with a slotted head designed to fasten skull plates (i.e., plates with a central convex curvature matching the curvature of the forehead, side, or rear areas of the human adult) to the intact cranial bones. It is typically made of metal [e.g., stainless steel, titanium (Ti)] and has a length and diameter appropriate to match the plate holes and the cranial bones. It is used mainly in neurosurgical procedures intended to fix cranioplasty plates used to repair defects created or caused by injury, surgical intervention for tumour removal, or 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
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
G28441001KTC Burr Hole Cover410-012022-06-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08806390889049Leforte Neuro System Bone PlateJeil Medical CorporationHBW2023-11-30
07613327543032DELTAStryker Leibinger GmbH & Co. KGHBW2020-12-15
08809595972837Neuro Plating SystemOSTEONIC CO.,Ltd.HBW2019-12-30
08809595972868Neuro Plating SystemOSTEONIC CO.,Ltd.HBW2019-12-30
08809595972882Neuro Plating SystemOSTEONIC CO.,Ltd.HBW2019-12-30
08809595972707Neuro Plating SystemOSTEONIC CO.,Ltd.HBW2019-02-13
08809595972714Neuro Plating SystemOSTEONIC CO.,Ltd.HBW2019-02-13
08809595972721Neuro Plating SystemOSTEONIC CO.,Ltd.HBW2019-02-13
07613327423648DELTAStryker Leibinger GmbH & Co. KGHBW2018-05-22
07613327423655DELTAStryker Leibinger GmbH & Co. KGHBW2018-05-22
07613327423662DELTAStryker Leibinger GmbH & Co. KGHBW2018-05-22
07613327177534DELTAStryker Leibinger GmbH & Co. KGHBW2018-04-16
08809265151982Leforte Neuro System Bone PlateJeil Medical CorporationHBW2018-04-12
08806390862271Leforte Neuro System Bone PlateJeil Medical CorporationHBW2018-02-26
08806390861953Leforte Neuro System Bone PlateJeil Medical CorporationHBW2018-01-22
08806390855150Sterile NS SystemJeil Medical CorporationHBW2017-10-13
08806390855174Sterile NS SystemJeil Medical CorporationHBW2017-10-13
08806390855198Sterile NS SystemJeil Medical CorporationHBW2017-10-13
08806390855211Sterile NS SystemJeil Medical CorporationHBW2017-10-13
08806390854641Sterile NS SystemJeil Medical CorporationHBW2017-09-20
07613327177510DELTAStryker Leibinger GmbH & Co. KGHBW2017-03-09
07613327177541DELTAStryker Leibinger GmbH & Co. KGHBW2017-03-09
10887587057255RapidSorbSynthes GmbHHBW2016-10-07
10887587057262RapidSorbSynthes GmbHHBW2016-10-07
10887587057279RapidSorbSynthes GmbHHBW2016-10-07
10887587061573RapidSorbSynthes GmbHHBW2016-10-07
10887587061580RapidSorbSynthes GmbHHBW2016-10-07
10887587061597RapidSorbSynthes GmbHHBW2016-10-07
10887587061603RapidSorbSynthes GmbHHBW2016-10-07
10887587066929RapidSorbSynthes GmbHHBW2016-10-07