FDA.reportPublic FDA data

Neuro Plating System

Primary DI
08809595972967
Brand
Neuro Plating System
Company
OSTEONIC CO.,Ltd.
Model
TSN-013
Device description
1x Magazine + 1x Cover + 6x Screws 3mm
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
K183352000
K190811000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K183352000Optimus Neuro SystemOsteonic Co., Ltd.2019-01-02GWO
K190811000Optimus NEURO System - Sterile KitOsteonic Co., Ltd.2019-11-27GWO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809595972967PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809595972967088095959729678809595972967

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
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
00810125929663CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-06-02
00810125929670FUSION SKULL IMPLANTKELYNIAM GLOBAL, INC.GWO2026-06-02
00810125929625CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-06-01
00810125929632CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-06-01
00810125929649CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-06-01
00810125929656CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-06-01
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 CorporationGWO2022-05-03
08806390888851Leforte Neuro System Bone PlateJeil Medical CorporationGXR2022-05-03
07613327543032DELTAStryker Leibinger GmbH & Co. KGGXR2020-12-15
07613327543032DELTAStryker Leibinger GmbH & Co. KGHBW2020-12-15
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