FDA.reportPublic FDA data

PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)

Primary DI
06903195108015
Brand
PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)
Company
Kontour(Xi'An) Medical Technology Co.,Ltd.
Model
KT-T2L10H2
Catalog number
CF26020011
Published
2022-12-08
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Safe
Single use
true

Product Codes#

Code, Name table
CodeName
GXNPlate, Cranioplasty, Preformed, Non-Alterable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXNPlate, Cranioplasty, Preformed, Non-AlterableNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06903195108015PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06903195108015069031951080156903195108015

GMDN Terms#

Term, Definition table
TermDefinition
Cranioplasty plate, non-alterableAn implantable shield designed to repair larger skull defects that is preformed before surgery and typically made of sheets of material [e.g., stainless steel, vitallium, titanium (Ti), plastic resins] that cannot 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
529652129
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06903195108008PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)KT-T2L9H2CF260200102022-12-08
06903195108039PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)KT-T2L12H2CF260200132022-12-08
06903195108046PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)KT-T2L13H2CF260200142022-12-08
06903195108053PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)KT-T2L14H2CF260200152022-12-08
06903195108060PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)KT-T2L15H2CF260200162022-12-08
06903195108077PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)KT-T2L16H2CF260200172022-12-08
06903195108084PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)KT-T2L17H2CF260200182022-12-08
06903195108091PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)KT-T3L1H1CF260300012022-12-08
06903195108107PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)KT-T3L2H1CF260300022022-12-08
06903195108114PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)KT-T3L3H1CF260300032022-12-08
06903195108121PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)KT-T3L4H1CF260300042022-12-08
06903195108138PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)KT-T3L5H1CF260300052022-12-08
06903195108145PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)KT-T3L6H1CF260300062022-12-08
06903195108152PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)KT-T3L7H1CF260300072022-12-08
06903195108169PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)KT-T3L18H1CF260300082022-12-08
06903195108176PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)KT-T3L8H2CF260300092022-12-08
06903195108183PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)KT-T3L9H2CF260300102022-12-08
06903195108190PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)KT-T3L10H2CF260300112022-12-08
06903195108206PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)KT-T3L11H2CF260300122022-12-08
06903195108213PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)KT-T3L12H2CF260300132022-12-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810188324177HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-06-09
00810188324719HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-06-09
00810188324689HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-06-03
00810188324665HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-06-01
00810188324641HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-05-28
00810188324658HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-05-28
00810188324634HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-05-27
08859751210556METICULY Patient-specific titanium mesh implantMETICULY COMPANY LIMITEDGXN2026-03-05
08859751210563METICULY Patient-specific titanium mesh implantMETICULY COMPANY LIMITEDGXN2026-03-05
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08859751216206METICULY Patient-specific titanium mesh implantMETICULY COMPANY LIMITEDGXN2026-03-05
08859751216312METICULY Patient-specific titanium mesh implantMETICULY COMPANY LIMITEDGXN2026-03-05
08859751216329METICULY Patient-specific titanium mesh implantMETICULY COMPANY LIMITEDGXN2026-03-05
08859751216336METICULY Patient-specific titanium mesh implantMETICULY COMPANY LIMITEDGXN2026-03-05
08859751216343METICULY Patient-specific titanium mesh implantMETICULY COMPANY LIMITEDGXN2026-03-05
08859751216411METICULY Patient-specific titanium mesh implantMETICULY COMPANY LIMITEDGXN2026-03-05
08859751216428METICULY Patient-specific titanium mesh implantMETICULY COMPANY LIMITEDGXN2026-03-05
08859751216435METICULY Patient-specific titanium mesh implantMETICULY COMPANY LIMITEDGXN2026-03-05
08859751216442METICULY Patient-specific titanium mesh implantMETICULY COMPANY LIMITEDGXN2026-03-05
00810007631271AccuShapeMedcadGXN2023-06-23
00810007631288AccuShapeMedcadGXN2023-06-23
00810007631295AccuShapeMedcadGXN2023-06-23
00810077248829HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2023-01-16
00810077248836HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2023-01-16
00810077248973HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2023-01-09
00810077248775HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2023-01-03
00810077248706HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2022-12-21
00810077248850HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2022-12-21
00810077248904HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2022-12-21
00810077248911HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2022-12-21