FDA.reportPublic FDA data

CUSTOMIZED SKULL IMPLANT (CSI)

Primary DI
00810228570571
Brand
CUSTOMIZED SKULL IMPLANT (CSI)
Company
KELYNIAM GLOBAL, INC.
Model
PEEK-IM1004
Catalog number
PEEK-IM1004
Device description
PEEK Customized Skull Implant, X-LARGE CSI100726-WR1
Published
2026-10-15
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
00810228570571PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810228570571008102285705718102285705710810228570571

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
00810228570649FUSION SKULL IMPLANTFUSION-IM3001FUSION-IM30012026-10-28
00810228570656FUSION SKULL IMPLANTFUSION-IM3003FUSION-IM30032026-10-28
00810228570663CUSTOMIZED SKULL IMPLANT (CSI)PEEK-IM1004PEEK-IM10042026-10-28
00810228570618FUSION SKULL IMPLANTFUSION-IM3001FUSION-IM30012026-10-22
00810228570625FUSION SKULL IMPLANTFUSION-IM3004FUSION-IM30042026-10-22
00810228570632CUSTOMIZED SKULL IMPLANT (CSI)PEEK-IM1003PEEK-IM10032026-10-22
00810228570588CUSTOMIZED SKULL IMPLANT (CSI)PEEK-IM1004PEEK-IM10042026-10-15
00810228570595CUSTOMIZED SKULL IMPLANT (CSI)PEEK-IM1001PEEK-IM10012026-10-15
00810228570601FUSION SKULL IMPLANTFUSION-IM3004FUSION-IM30042026-10-15
00810228570540CUSTOMIZED SKULL IMPLANT (CSI)PEEK-IM1004PEEK-IM10042026-10-07
00810228570557CUSTOMIZED SKULL IMPLANT (CSI)PEEK-IM1002PEEK-IM10022026-10-07
00810228570564CUSTOMIZED SKULL IMPLANT (CSI)PEEK-IM1003PEEK-IM10032026-10-07
00810228570519CUSTOMIZED SKULL IMPLANT (CSI)PEEK-IM1004PEEK-IM10042026-10-01
00810228570526FUSION SKULL IMPLANTFUSION-IM3004FUSION-IM30042026-10-01
00810228570533CUSTOMIZED SKULL IMPLANT (CSI)PEEK-IM1004PEEK-IM10042026-10-01
00810228570465FUSION SKULL IMPLANTFUSION-IM3003FUSION-IM30032026-09-28
00810228570472CUSTOMIZED SKULL IMPLANT (CSI)PEEK-IM1004PEEK-IM10042026-09-28
00810228570489CUSTOMIZED SKULL IMPLANT (CSI)PEEK-IM1004PEEK-IM10042026-09-28
00810228570496FUSION SKULL IMPLANTFUSION-IM3004FUSION-IM30042026-09-28
00810228570502FUSION SKULL IMPLANTFUSION-IM3004FUSION-IM30042026-09-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800089428151Leforte Neuro System Bone PlateJeil Medical CorporationGWO2026-11-04
08806390889100Leforte Neuro System Bone PlateJeil Medical CorporationGWO2026-11-04
08806390889087Leforte Neuro System Bone PlateJeil Medical CorporationGWO2026-11-01
00810228570649FUSION SKULL IMPLANTKELYNIAM GLOBAL, INC.GWO2026-10-28
00810228570656FUSION SKULL IMPLANTKELYNIAM GLOBAL, INC.GWO2026-10-28
00810228570663CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-10-28
00810228570618FUSION SKULL IMPLANTKELYNIAM GLOBAL, INC.GWO2026-10-22
00810228570625FUSION SKULL IMPLANTKELYNIAM GLOBAL, INC.GWO2026-10-22
00810228570632CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-10-22
00810228570588CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-10-15
00810228570595CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-10-15
00810228570601FUSION SKULL IMPLANTKELYNIAM GLOBAL, INC.GWO2026-10-15
00810228570540CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-10-07
00810228570557CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-10-07
00810228570564CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-10-07
00810228570519CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-10-01
00810228570526FUSION SKULL IMPLANTKELYNIAM GLOBAL, INC.GWO2026-10-01
00810228570533CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-10-01
00810228570465FUSION SKULL IMPLANTKELYNIAM GLOBAL, INC.GWO2026-09-28
00810228570472CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-09-28
00810228570489CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-09-28
00810228570496FUSION SKULL IMPLANTKELYNIAM GLOBAL, INC.GWO2026-09-28
00810228570502FUSION SKULL IMPLANTKELYNIAM GLOBAL, INC.GWO2026-09-28
00810228570458CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-09-21
00810228570373CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-09-18
00810228570380CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-09-18
00810228570397FUSION SKULL IMPLANTKELYNIAM GLOBAL, INC.GWO2026-09-18
00810228570403CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-09-18
00810228570410FUSION SKULL IMPLANTKELYNIAM GLOBAL, INC.GWO2026-09-18
00810228570427FUSION SKULL IMPLANTKELYNIAM GLOBAL, INC.GWO2026-09-18