FDA.reportPublic FDA data

Neuro Plating System

Primary DI
08809399745279
Brand
Neuro Plating System
Company
OSTEONIC CO.,Ltd.
Model
N18004
Device description
1 Rescue screw 4mm
Published
2019-02-13
Public version status
Update
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
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
K141911000
K190811000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141911000OPTIMUS NEURO SYSTEMOsteonic Co., Ltd.2015-02-10GWO
K190811000Optimus NEURO System - Sterile KitOsteonic Co., Ltd.2019-11-27GWO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809399745279PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809399745279088093997452798809399745279

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
688999370
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
08800071055471ASTERN3A.202302026-05-18
08800071055457ASTERN3A.201902026-04-27
08800071055464ASTERN3A.202102026-04-27
08800071055440ASTERN3A.201702026-03-19
08809416064703SignexA2C.080702025-06-24
08809416064802SignexA1R.080102025-06-24
08809416065267SignexA2A.100502025-06-24
08809416065274SignexA2A.100802025-06-24
08809416065281SignexA2B.100802025-06-24
08809416065298SignexA2C.100502025-06-24
08809416065410SignexA2A.130502025-06-24
08809595977733SignexA2A.080402025-06-24
08809595977740SignexA2A.080602025-06-24
08809595977757SignexA2A.081202025-06-24
08809595977764SignexA2A.100402025-06-24
08809595977818SignexA2B.080802025-06-24
08809595977832SignexA2C.080602025-06-24
08809416064581SignexA1A.060402025-07-01
08809416064598SignexA1A.061202025-07-01
08809416064604SignexA1C.060702025-07-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800089428151Leforte Neuro System Bone PlateJeil Medical CorporationGXR2026-11-04
08800089428151Leforte Neuro System Bone PlateJeil Medical CorporationHBW2026-11-04
08800089428151Leforte Neuro System Bone PlateJeil Medical CorporationGWO2026-11-04
08806390889100Leforte Neuro System Bone PlateJeil Medical CorporationGWO2026-11-04
08806390889100Leforte Neuro System Bone PlateJeil Medical CorporationGXR2026-11-04
08806390889100Leforte Neuro System Bone PlateJeil Medical CorporationHBW2026-11-04
08806390889087Leforte Neuro System Bone PlateJeil Medical CorporationGWO2026-11-01
08806390889087Leforte Neuro System Bone PlateJeil Medical CorporationGXR2026-11-01
08806390889087Leforte Neuro System Bone PlateJeil Medical CorporationHBW2026-11-01
00810228570649FUSION SKULL IMPLANTKELYNIAM GLOBAL, INC.GWO2026-10-28
00810228570656FUSION SKULL IMPLANTKELYNIAM GLOBAL, INC.GWO2026-10-28
00810228570663CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-10-28
00810228570618FUSION SKULL IMPLANTKELYNIAM GLOBAL, INC.GWO2026-10-22
00810228570625FUSION SKULL IMPLANTKELYNIAM GLOBAL, INC.GWO2026-10-22
00810228570632CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-10-22
00810228570571CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-10-15
00810228570588CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-10-15
00810228570595CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-10-15
00810228570601FUSION SKULL IMPLANTKELYNIAM GLOBAL, INC.GWO2026-10-15
00810228570540CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-10-07
00810228570557CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-10-07
00810228570564CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-10-07
00810228570519CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-10-01
00810228570526FUSION SKULL IMPLANTKELYNIAM GLOBAL, INC.GWO2026-10-01
00810228570533CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-10-01
00810228570465FUSION SKULL IMPLANTKELYNIAM GLOBAL, INC.GWO2026-09-28
00810228570472CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-09-28
00810228570489CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-09-28
00810228570496FUSION SKULL IMPLANTKELYNIAM GLOBAL, INC.GWO2026-09-28
00810228570502FUSION SKULL IMPLANTKELYNIAM GLOBAL, INC.GWO2026-09-28