FDA.reportPublic FDA data

KELYNIAM CSI

Primary DI
00810125923135
Brand
KELYNIAM CSI
Company
KELYNIAM GLOBAL, INC.
Model
PEEK-IM1004
Catalog number
PEEK-IM1004
Device description
PEEK Customized Cranial Implant, X-LARGECSI103123-RD1
Published
2023-11-07
Public version status
New
Distribution status
Not in Commercial Distribution
MRI safety
MR Safe
Rx
true
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K103582000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K103582000KELYNIAM CUSTOM SKULL IMPLANT (CSI)Kelyniam Global, Inc.2011-04-14GXN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810125923135PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810125923135008101259231358101259231350810125923135

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
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810125929861CUSTOMIZED SKULL IMPLANT (CSI)PEEK-IM1004PEEK-IM10042026-07-06
00810125929878CUSTOMIZED SKULL IMPLANT (CSI)PEEK-IM1001PEEK-IM10012026-07-06
00810125929885CUSTOMIZED SKULL IMPLANT (CSI)PEEK-IM1001PEEK-IM10012026-07-06
00810125929823CUSTOMIZED SKULL IMPLANT (CSI)PEEK-IM1004PEEK-IM10042026-06-24
00810125929830FUSION SKULL IMPLANTFUSION-IM3004FUSION-IM30042026-06-24
00810125929847CUSTOMIZED SKULL IMPLANT (CSI)PEEK-IM1004PEEK-IM10042026-06-24
00810125929854CUSTOMIZED SKULL IMPLANT (CSI)PEEK-IM1001PEEK-IM10012026-06-24
00810125929687CUSTOMIZED SKULL IMPLANT (CSI)PEEK-IM1004PEEK-IM10042026-06-10
00810125929694CUSTOMIZED SKULL IMPLANT (CSI)PEEK-IM1004PEEK-IM10042026-06-10
00810125929700CUSTOMIZED SKULL IMPLANT (CSI)PEEK-IM1003PEEK-IM10032026-06-10
00810125929717FUSION SKULL IMPLANTFUSION-IM3003FUSION-IM30032026-06-10
00810125929724CUSTOMIZED SKULL IMPLANT (CSI)PEEK-IM1004PEEK-IM10042026-06-10
00810125929731CUSTOMIZED SKULL IMPLANT (CSI)PEEK-IM1004PEEK-IM10042026-06-10
00810125929748FUSION SKULL IMPLANTFUSION-IM3001FUSION-IM30012026-06-10
00810125929755CUSTOMIZED CRANIOFACIAL IMPLANT (CCI)PEEK-IM2003PEEK-IM20032026-06-10
00810125929663CUSTOMIZED SKULL IMPLANT (CSI)PEEK-IM1004PEEK-IM10042026-06-02
00810125929670FUSION SKULL IMPLANTFUSION-IM3001FUSION-IM30012026-06-02
00810125929625CUSTOMIZED SKULL IMPLANT (CSI)PEEK-IM1004PEEK-IM10042026-06-01
00810125929632CUSTOMIZED SKULL IMPLANT (CSI)PEEK-IM1004PEEK-IM10042026-06-01
00810125929649CUSTOMIZED SKULL IMPLANT (CSI)PEEK-IM1004PEEK-IM10042026-06-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810188324924HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-07-09
00810188324702HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-07-07
00810188324917HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-07-06
00810188324818HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-06-26
00810188324849HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-06-26
00810188324856HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-06-26
00810188324672HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-06-22
00810188324757HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-06-22
00810188324788HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-06-22
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
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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