FDA.reportPublic FDA data

CUSTOMIZED SKULL IMPLANT (CSI)

Primary DI
00810125929557
Brand
CUSTOMIZED SKULL IMPLANT (CSI)
Company
KELYNIAM GLOBAL, INC.
Model
PEEK-IM1004
Catalog number
PEEK-IM1004
Device description
PEEK Customized Skull Implant, X-LARGECSI070725-MR2
Published
2026-05-21
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
GWOPlate, Cranioplasty, Preformed, Alterable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWOPlate, Cranioplasty, Preformed, AlterableNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K182711000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182711000Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI)Kelyniam Global, Inc.2019-05-21GWO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810125929557PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810125929557008101259295578101259295570810125929557

GMDN Terms#

Term, Definition table
TermDefinition
Cranioplasty plate, alterableAn implantable shield designed to repair larger skull defects that is preformed before surgery and typically made of sheets of material (e.g., tantalum) that can 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
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00810125929410KELYNIAM CSIPEEK-IM1004PEEK-IM10042026-04-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08806390889049Leforte Neuro System Bone PlateJeil Medical CorporationGWO2023-11-30
G28440901KTC Burr Hole CoverNeurovention LLCGWO2022-06-21
G28441001KTC Burr Hole CoverNeurovention LLCGWO2022-06-21
08806390888851Leforte Neuro System Bone PlateJeil Medical CorporationGWO2022-05-03
09349797002547StarPoreANATOMICS PTY LTDGWO2020-04-03
09349797002561StarPoreANATOMICS PTY LTDGWO2020-04-03
09349797000208StarPoreANATOMICS PTY LTDGWO2020-01-08
09349797000222StarPoreANATOMICS PTY LTDGWO2020-01-08
08809595972844Neuro Plating SystemOSTEONIC CO.,Ltd.GWO2019-12-30
08809595972851Neuro Plating SystemOSTEONIC CO.,Ltd.GWO2019-12-30
08809595972875Neuro Plating SystemOSTEONIC CO.,Ltd.GWO2019-12-30
08809595972899Neuro Plating SystemOSTEONIC CO.,Ltd.GWO2019-12-30
08809416061542Neuro Plating SystemOSTEONIC CO.,Ltd.GWO2019-02-14
08809416061559Neuro Plating SystemOSTEONIC CO.,Ltd.GWO2019-02-14
08809416061566Neuro Plating SystemOSTEONIC CO.,Ltd.GWO2019-02-14
08809416061573Neuro Plating SystemOSTEONIC CO.,Ltd.GWO2019-02-14
08809416061580Neuro Plating SystemOSTEONIC CO.,Ltd.GWO2019-02-14
08809416061603Neuro Plating SystemOSTEONIC CO.,Ltd.GWO2019-02-14
08809416061627Neuro Plating SystemOSTEONIC CO.,Ltd.GWO2019-02-14
08809416061634Neuro Plating SystemOSTEONIC CO.,Ltd.GWO2019-02-14
08809416061641Neuro Plating SystemOSTEONIC CO.,Ltd.GWO2019-02-14
08809416061658Neuro Plating SystemOSTEONIC CO.,Ltd.GWO2019-02-14
08809416061665Neuro Plating SystemOSTEONIC CO.,Ltd.GWO2019-02-14
08809416061672Neuro Plating SystemOSTEONIC CO.,Ltd.GWO2019-02-14
08809416061733Neuro Plating SystemOSTEONIC CO.,Ltd.GWO2019-02-14
08809539691695Neuro Plating SystemOSTEONIC CO.,Ltd.GWO2019-02-13
08809399740946Neuro Plating SystemOSTEONIC CO.,Ltd.GWO2019-02-13
08809399740953Neuro Plating SystemOSTEONIC CO.,Ltd.GWO2019-02-13
08809399745231Neuro Plating SystemOSTEONIC CO.,Ltd.GWO2019-02-13
08809399745248Neuro Plating SystemOSTEONIC CO.,Ltd.GWO2019-02-13