FDA.reportPublic FDA data

Kelynaim CSI

Primary DI
00817580021457
Brand
Kelynaim CSI
Company
KELYNIAM GLOBAL, INC.
Model
PEEK-IM1004
Catalog number
PEEK-IM1004
Device description
PEEK Customized Cranial Implant, X-large
Published
2016-12-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
false
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
00817580021457PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817580021457008175800214578175800214570817580021457

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
785088829
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
true
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810125929557CUSTOMIZED SKULL IMPLANT (CSI)PEEK-IM1004PEEK-IM10042026-05-21
00810125929564CUSTOMIZED SKULL IMPLANT (CSI)PEEK-IM1004PEEK-IM10042026-05-21
00810125929571CUSTOMIZED SKULL IMPLANT (CSI)PEEK-IM1004PEEK-IM10042026-05-21
00810125929588CUSTOMIZED SKULL IMPLANT (CSI)PEEK-IM1001PEEK-IM10012026-05-21
00810125929595CUSTOMIZED SKULL IMPLANT (CSI)PEEK-IM1003PEEK-IM10032026-05-21
00810125929601CUSTOMIZED SKULL IMPLANT (CSI)PEEK-IM1004PEEK-IM10042026-05-21
00810125929618FUSION SKULL IMPLANTFUSION-IM3001FUSION-IM30012026-05-21
00810125929533CUSTOMIZED SKULL IMPLANT (CSI)PEEK-IM1004PEEK-IM10042026-05-11
00810125929540CUSTOMIZED SKULL IMPLANT (CSI)PEEK-IM1001PEEK-IM10012026-05-11
00810125929434CUSTOMIZED SKULL IMPLANT (CSI)PEEK-IM1004PEEK-IM10042026-04-30
00810125929441CUSTOMIZED SKULL IMPLANT (CSI)PEEK-IM1004PEEK-IM10042026-04-30
00810125929458CUSTOMIZED SKULL IMPLANT (CSI)PEEK-IM1004PEEK-IM10042026-04-30
00810125929465CUSTOMIZED SKULL IMPLANT (CSI)PEEK-IM1004PEEK-IM10042026-04-30
00810125929472CUSTOMIZED SKULL IMPLANT (CSI)PEEK-IM1002PEEK-IM10022026-04-30
00810125929489CUSTOMIZED SKULL IMPLANT (CSI)PEEK-IM1004PEEK-IM10042026-04-30
00810125929496CUSTOMIZED SKULL IMPLANT (CSI)PEEK-IM1004PEEK-IM10042026-04-30
00810125929502CUSTOMIZED SKULL IMPLANT (CSI)PEEK-IM1001PEEK-IM10012026-04-30
00810125929519CUSTOMIZED SKULL IMPLANT (CSI)PEEK-IM1004PEEK-IM10042026-04-30
00810125929526CUSTOMIZED SKULL IMPLANT (CSI)PEEK-IM1004PEEK-IM10042026-04-30
00810125929403KELYNIAM CSIPEEK-IM1004PEEK-IM10042026-04-14

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
00810077249031HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2023-01-20
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00810077248980HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2023-01-05
00810077248775HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2023-01-03
00810077248997HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2022-12-22
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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