FDA.reportPublic FDA data

Kelyniam CSI

Primary DI
00817580021488
Brand
Kelyniam CSI
Company
KELYNIAM GLOBAL, INC.
Model
PEEK-IM1001
Catalog number
PEEK-IM1001
Device description
PEEK Customized Cranial Implant, Small & Small
Published
2017-05-09
Public version status
Update
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
GXNPlate, Cranioplasty, Preformed, Non-Alterable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXNPlate, Cranioplasty, Preformed, Non-AlterableNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K121755000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K121755000CUSTOM CRANIOFACIAL IMPLANT (CCI)Kelyniam Global, Inc.2012-09-25GXN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817580021488PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817580021488008175800214888175800214880817580021488

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
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
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00810125929939CUSTOMIZED SKULL IMPLANT (CSI)PEEK-IM1002PEEK-IM10022026-07-13
00810125929946CUSTOMIZED SKULL IMPLANT (CSI)PEEK-IM1004PEEK-IM10042026-07-13
00810125929953CUSTOMIZED SKULL IMPLANT (CSI)PEEK-IM1001PEEK-IM10012026-07-13
00810125929960CUSTOMIZED SKULL IMPLANT (CSI)PEEK-IM1001PEEK-IM10012026-07-13
00810125929977CUSTOMIZED SKULL IMPLANT (CSI)PEEK-IM1004PEEK-IM10042026-07-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00810188324672HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-06-22
00810188324757HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-06-22
00810188324788HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-06-22
00810188324177HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-06-09
00810188324719HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-06-09
00810188324689HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-06-03
00810188324665HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-06-01
00810188324641HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-05-28
00810188324658HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-05-28