FDA.reportPublic FDA data

Leforte Neuro System Bone Plate

Primary DI
08809265156208
Brand
Leforte Neuro System Bone Plate
Company
Jeil Medical Corporation
Model
N16-YP-005S
Published
2015-09-24
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
JEYPlate, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWOPlate, Cranioplasty, Preformed, AlterableNeurology2
GXRCover, Burr HoleNeurology2
HBWFastener, Plate, CranioplastyNeurology2
JEYPlate, BoneDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K091679000
K103778000
K112812000
K141452000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K091679000LEFORTE SYSTEM BONE PLATEJeil Medical Corporation2009-10-02JEY
K103778000LEFORTE NEURO SYSTEM BONE PLATEJeil Medical Corporation2011-01-26JEY
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
08809265156208PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809265156208088092651562088809265156208

GMDN Terms#

Term, Definition table
TermDefinition
Craniofacial fixation plate, non-bioabsorbableA small implantable plate/set of plates designed to be attached with screws to craniofacial bone (including the maxilla and/or mandible), to bridge and stabilize a fracture gap or craniotomy flap, and/or cover a burr hole; the material cannot be chemically degraded or absorbed by natural body processes. It is available in a variety of designs (e.g., Y-plate, curved plate, mesh-panel, burr hole cover) and includes implant-grade metal; in addition to the plate(s) bone screws may be included.

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
08800089458912Leforte MMF SystemJeil Medical CorporationJEY2026-04-09
08800089458929Leforte MMF SystemJeil Medical CorporationJEY2026-04-09
G28436102NuCrani Large PlateNeurovention LLCGXR2022-06-21
G28440901KTC Burr Hole CoverNeurovention LLCGWO2022-06-21
G28441001KTC Burr Hole CoverNeurovention LLCGWO2022-06-21
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. KGGXR2018-05-22
07613327423655DELTAStryker Leibinger GmbH & Co. KGHBW2018-05-22
07613327423662DELTAStryker Leibinger GmbH & Co. KGHBW2018-05-22
07613327423662DELTAStryker Leibinger GmbH & Co. KGJEY2018-05-22
07613327423679DELTAStryker Leibinger GmbH & Co. KGGXR2018-05-22
07613327423679DELTAStryker Leibinger GmbH & Co. KGJEY2018-05-22
07613327177527DELTAStryker Leibinger GmbH & Co. KGJEY2018-04-16
07613327177527DELTAStryker Leibinger GmbH & Co. KGGXR2018-04-16
07613327177534DELTAStryker Leibinger GmbH & Co. KGGXR2018-04-16
07613327177534DELTAStryker Leibinger GmbH & Co. KGHBW2018-04-16
07613327400953DELTAStryker Leibinger GmbH & Co. KGGXR2017-12-05
07613327400953DELTAStryker Leibinger GmbH & Co. KGJEY2017-12-05
08437006085076Cranial COVER “14 mm / 13 mm”NEOS SURGERY SLGXR2017-05-11
08437006085083Cranial COVER “10-12 mm”NEOS SURGERY SLGXR2017-05-11
07613327177510DELTAStryker Leibinger GmbH & Co. KGJEY2017-03-09
07613327177510DELTAStryker Leibinger GmbH & Co. KGHBW2017-03-09
07613327177541DELTAStryker Leibinger GmbH & Co. KGHBW2017-03-09
07613327177541DELTAStryker Leibinger GmbH & Co. KGGXR2017-03-09
08800000920658SMARTbuilder SystemOsstem Implant Co., Ltd.JEY2015-10-14
08800000920665SMARTbuilder SystemOsstem Implant Co., Ltd.JEY2015-10-14
08800000920672SMARTbuilder SystemOsstem Implant Co., Ltd.JEY2015-10-14