FDA.reportPublic FDA data

KELYNIAM CSI

Primary DI
00810125929328
Brand
KELYNIAM CSI
Company
KELYNIAM GLOBAL, INC.
Model
PEEK-IM1004
Catalog number
PEEK-IM1004
Device description
PEEK Customized Cranial Implant, X-LARGECSI021926-CH1
Published
2026-03-30
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
00810125929328PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810125929328008101259293288101259293280810125929328

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
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
00810228570175FUSION SKULL IMPLANTFUSION-IM3004FUSION-IM30042026-08-17
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810188325327HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-08-19
00810188325334HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-08-19
00810188325297HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-08-17
00810188325259HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-08-07
00810188325266HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-08-07
00810188325044HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-08-03
00810188325181HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-08-03
00810188325204HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-08-03
00810188325174HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-07-31
00810188325129HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-07-28
00810188325105HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-07-27
00810188325099HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-07-23
00810188325112HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-07-23
00810188325068HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-07-20
00810188325075HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-07-20
00810188325082HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-07-20
00810188325051HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-07-17
00810188324955HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-07-14
00810188325013HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-07-14
00810188324795HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-07-13
00810188324948HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-07-13
00810188324986HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-07-13
00810188324931HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-07-10
00810188324979HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-07-10
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