FDA.reportPublic FDA data

KELYNIAM CSI

Primary DI
00810125929120
Brand
KELYNIAM CSI
Company
KELYNIAM GLOBAL, INC.
Model
PEEK-IM1002
Catalog number
PEEK-IM1002
Device description
PEEK Customized Cranial Implant, MEDIUMCSI022326-EH1
Published
2026-03-06
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
00810125929120PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810125929120008101259291208101259291200810125929120

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
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
00810228570571CUSTOMIZED SKULL IMPLANT (CSI)PEEK-IM1004PEEK-IM10042026-10-15
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

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Primary DI, Brand, Company table
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00855113008807ClearFit Ti RingLONGEVITI NEURO SOLUTIONS LLCGXN2026-10-26
00855113008814ClearFit Ti RingLONGEVITI NEURO SOLUTIONS LLCGXN2026-10-26
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