FDA.reportPublic FDA data

Leforte Neuro System Bone Plate

Primary DI
08809265151982
Brand
Leforte Neuro System Bone Plate
Company
Jeil Medical Corporation
Model
N16-QD-006
Published
2018-04-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWOPlate, Cranioplasty, Preformed, AlterableNeurology2
GXRCover, Burr HoleNeurology2
HBWFastener, Plate, CranioplastyNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K112812000
K141452000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K112812000LEFORTE NEURO SYSTEM BONE PLATEJeil Medical Corporation2012-02-22GWO
K141452000LEFORTE NEURO SYSTEM BONE PLATE AND SCREWJeil Medical Corporation2014-07-02GWO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809265151982PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809265151982088092651519828809265151982

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
688811603
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800089423880Surgical Instrument111-0212026-04-09
08800089458875Leforte MMF System20-MS-0062026-04-09
08800089458882Leforte MMF System20-MS-0082026-04-09
08800089458899Leforte MMF System20-MS-0102026-04-09
08800089458905Leforte MMF System20-MS-0122026-04-09
08800089458912Leforte MMF System20L-MP-L132026-04-09
08800089458929Leforte MMF System20L-MP-U132026-04-09
08800089458936Leforte MMF System20L-MS-0062026-04-09
08800089458943Leforte MMF System20L-MS-0082026-04-09
08800089458950Leforte MMF System20L-MS-0102026-04-09
08800089458967Leforte MMF System20L-MS-0122026-04-09
08800089458974Leforte MMF System20L-MS-F062026-04-09
08800089458981Leforte MMF System20L-MS-F082026-04-09
08800089458998Leforte MMF System20L-MS-F102026-04-09
08800089459001Leforte MMF System20L-MS-F122026-04-09
08800089466801Surgical Instrument112-1942026-04-09
08800089476886Surgical Instrument111-5912026-04-09
08800089476893Surgical Instrument111-6362026-04-09
08806390880350ARIX Rib System Bone Plate24-CVRB-0042022-12-06
08806390880367ARIX Rib System Bone Plate24-CVRB-0062022-12-06

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
08806390889049Leforte Neuro System Bone PlateJeil Medical CorporationHBW2023-11-30
G28436102NuCrani Large PlateNeurovention LLCGXR2022-06-21
G28440901KTC Burr Hole CoverNeurovention LLCGWO2022-06-21
G28441001KTC Burr Hole CoverNeurovention LLCGWO2022-06-21
08806390888851Leforte Neuro System Bone PlateJeil Medical CorporationGXR2022-05-03
08806390888851Leforte Neuro System Bone PlateJeil Medical CorporationGWO2022-05-03
07613327543032DELTAStryker Leibinger GmbH & Co. KGHBW2020-12-15
07613327543032DELTAStryker Leibinger GmbH & Co. KGGXR2020-12-15
07613327423648DELTAStryker Leibinger GmbH & Co. KGHBW2018-05-22
07613327423648DELTAStryker Leibinger GmbH & Co. KGGXR2018-05-22
07613327423655DELTAStryker Leibinger GmbH & Co. KGHBW2018-05-22
07613327423655DELTAStryker Leibinger GmbH & Co. KGGXR2018-05-22
07613327423662DELTAStryker Leibinger GmbH & Co. KGHBW2018-05-22
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. KGHBW2018-04-16
07613327177534DELTAStryker Leibinger GmbH & Co. KGGXR2018-04-16
08806390862271Leforte Neuro System Bone PlateJeil Medical CorporationGWO2018-02-26
08806390862271Leforte Neuro System Bone PlateJeil Medical CorporationGXR2018-02-26
08806390862271Leforte Neuro System Bone PlateJeil Medical CorporationHBW2018-02-26
08806390861953Leforte Neuro System Bone PlateJeil Medical CorporationGXR2018-01-22
08806390861953Leforte Neuro System Bone PlateJeil Medical CorporationHBW2018-01-22
08806390861953Leforte Neuro System Bone PlateJeil Medical CorporationGWO2018-01-22