Kelyniam CSI

Basic Information

• Brand Name: Kelyniam CSI
• Primary DI: 00817580022151
• Version / Model: PEEK-IM1004
• Catalog Number: PEEK-IM1004
• Company Name: KELYNIAM GLOBAL, INC.
• Labeler DUNS: 785088829
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-07-23
• Public Version: 1
• Public Version Date: 2018-08-23
• Public Version Status: New
• Public Device Record Key: 5bd0d0c2-feef-4a9e-a5ba-da3ca595cb35
• Distribution End Date: 2018-07-23

Device Description

PEEK Customized Cranial Implant, X-Large

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: MR Safe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: Yes

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GXN	Plate, Cranioplasty, Preformed, Non-Alterable	Neurology	882.5330	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46268	Cranioplasty plate, non-alterable	An 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.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00817580022151	GS1

Premarket Submissions

Submission Number	Supplement Number
K103582	000