FDA.reportPublic FDA data

Neuro Plating System

Primary DI
08809595972882
Brand
Neuro Plating System
Company
OSTEONIC CO.,Ltd.
Model
TCN-012
Device description
5 x straight 2 hole plates 15.4mm + 5 self tapping screws Ø1.5 x 4.0mm + 5 self drilling screws Ø1.5 x 4.0mm
Published
2019-12-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
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
K190811000

Premarket Details#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809595972882PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809595972882088095959728828809595972882

GMDN Terms#

Term, Definition table
TermDefinition
Craniofacial fixation plate kit, non-bioabsorbableA collection of small sheets of firm material and bone screws, of various shapes/sizes, that are implanted onto fractured craniofacial bone (including the maxilla and/or mandible) to bridge and stabilize the fracture gap, and shield the site from stress as the bone heals; the components are made of a material that is not chemically degraded or absorbed by natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). Tools for implantation may be included. The device may also be used for craniofacial reconstructive procedures (e.g., to treat congenital malformations), endobrow fixation, or craniotomy flap fixation.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
688999370
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
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