FDA.reportPublic FDA data

CUSTOMIZED SKULL IMPLANT (CSI)

Primary DI
00810125929694
Brand
CUSTOMIZED SKULL IMPLANT (CSI)
Company
KELYNIAM GLOBAL, INC.
Model
PEEK-IM1004
Catalog number
PEEK-IM1004
Device description
PEEK Customized Skull Implant, X-LARGE CSI060226-ML1
Published
2026-06-10
Public version status
New
Distribution status
Not in Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
false
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
00810125929694PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810125929694008101259296948101259296940810125929694

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
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
false
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
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
00810125929656CUSTOMIZED SKULL IMPLANT (CSI)PEEK-IM1004PEEK-IM10042026-06-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810125929861CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-07-06
00810125929878CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-07-06
00810125929885CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-07-06
00810125929823CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-06-24
00810125929830FUSION SKULL IMPLANTKELYNIAM GLOBAL, INC.GWO2026-06-24
00810125929847CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-06-24
00810125929854CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-06-24
00810125929687CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-06-10
00810125929700CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-06-10
00810125929717FUSION SKULL IMPLANTKELYNIAM GLOBAL, INC.GWO2026-06-10
00810125929724CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-06-10
00810125929731CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-06-10
00810125929748FUSION SKULL IMPLANTKELYNIAM GLOBAL, INC.GWO2026-06-10
00810125929755CUSTOMIZED CRANIOFACIAL IMPLANT (CCI)KELYNIAM GLOBAL, INC.GWO2026-06-10
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 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
07613327300086NAStryker Leibinger GmbH & Co. KGGWO2021-01-27
07613327300109NAStryker Leibinger GmbH & Co. KGGWO2021-01-27
07613327300123NAStryker Leibinger GmbH & Co. KGGWO2021-01-27
08809416061542Neuro Plating SystemOSTEONIC CO.,Ltd.GWO2019-02-14
08809416061559Neuro Plating SystemOSTEONIC CO.,Ltd.GWO2019-02-14
08809416061566Neuro Plating SystemOSTEONIC CO.,Ltd.GWO2019-02-14