FDA.reportPublic FDA data

FUSION SKULL IMPLANT

Primary DI
00810228570175
Brand
FUSION SKULL IMPLANT
Company
KELYNIAM GLOBAL, INC.
Model
FUSION-IM3004
Catalog number
FUSION-IM3004
Device description
BCP PEEK Fusion Skull Implant, X-LARGE FSI081126-HB1
Published
2026-08-17
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
K250334000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K250334000Fusion Craniofacial Implant; Fusion Skull ImplantKelyniam Global, Inc.2025-07-25GWO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810228570175PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810228570175008102285701758102285701750810228570175

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
00810228570137CUSTOMIZED SKULL IMPLANT (CSI)PEEK-IM1004PEEK-IM10042026-08-17
00810228570144FUSION SKULL IMPLANTFUSION-IM3004FUSION-IM30042026-08-17
00810228570151CUSTOMIZED SKULL IMPLANT (CSI)PEEK-IM1004PEEK-IM10042026-08-17
00810228570168CUSTOMIZED SKULL IMPLANT (CSI)PEEK-IM1003PEEK-IM10032026-08-17
00810228570182FUSION SKULL IMPLANTFUSION-IM3004FUSION-IM30042026-08-17
00810125929991CUSTOMIZED SKULL IMPLANT (CSI)PEEK-IM1004PEEK-IM10042026-07-30
00810228570007FUSION SKULL IMPLANTFUSION-IM3004FUSION-IM30042026-07-30
00810228570014FUSION SKULL IMPLANTFUSION-IM3004FUSION-IM30042026-07-30
00810228570021FUSION SKULL IMPLANTFUSION-IM3003FUSION-IM30032026-07-30
00810228570038CUSTOMIZED SKULL IMPLANT (CSI)PEEK-IM1004PEEK-IM10042026-07-30
00810228570045FUSION SKULL IMPLANTFUSION-IM3003FUSION-IM30032026-07-30
00810228570052CUSTOMIZED SKULL IMPLANT (CSI)PEEK-IM1003PEEK-IM10032026-07-30
00810228570069CUSTOMIZED SKULL IMPLANT (CSI)PEEK-IM1003PEEK-IM10032026-07-30
00810228570076CUSTOMIZED SKULL IMPLANT (CSI)PEEK-IM1004PEEK-IM10042026-07-30
00810228570083CUSTOMIZED SKULL IMPLANT (CSI)PEEK-IM1004PEEK-IM10042026-07-30
00810228570090FUSION SKULL IMPLANTFUSION-IM3004FUSION-IM30042026-07-30
00810125929892CUSTOMIZED SKULL IMPLANT (CSI)PEEK-IM1004PEEK-IM10042026-07-13
00810125929908FUSION SKULL IMPLANTFUSION-IM3003FUSION-IM30032026-07-13
00810125929915CUSTOMIZED SKULL IMPLANT (CSI)PEEK-IM1003PEEK-IM10032026-07-13
00810125929922CUSTOMIZED SKULL IMPLANT (CSI)PEEK-IM1004PEEK-IM10042026-07-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810228570137CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-08-17
00810228570144FUSION SKULL IMPLANTKELYNIAM GLOBAL, INC.GWO2026-08-17
00810228570151CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-08-17
00810228570168CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-08-17
00810228570182FUSION SKULL IMPLANTKELYNIAM GLOBAL, INC.GWO2026-08-17
00810125929991CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-07-30
00810228570007FUSION SKULL IMPLANTKELYNIAM GLOBAL, INC.GWO2026-07-30
00810228570014FUSION SKULL IMPLANTKELYNIAM GLOBAL, INC.GWO2026-07-30
00810228570021FUSION SKULL IMPLANTKELYNIAM GLOBAL, INC.GWO2026-07-30
00810228570038CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-07-30
00810228570045FUSION SKULL IMPLANTKELYNIAM GLOBAL, INC.GWO2026-07-30
00810228570052CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-07-30
00810228570069CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-07-30
00810228570076CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-07-30
00810228570083CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-07-30
00810228570090FUSION SKULL IMPLANTKELYNIAM GLOBAL, INC.GWO2026-07-30
00810125929892CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-07-13
00810125929908FUSION SKULL IMPLANTKELYNIAM GLOBAL, INC.GWO2026-07-13
00810125929915CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-07-13
00810125929922CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-07-13
00810125929939CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-07-13
00810125929946CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-07-13
00810125929953CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-07-13
00810125929960CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-07-13
00810125929977CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-07-13
00810125929984CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-07-13
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