ELEOS™

Basic Information

• Brand Name: ELEOS™
• Primary DI: B278KSC01465E0
• Version / Model: KSC01465E
• Catalog Number: KSC01465E
• Company Name: ONKOS SURGICAL, INC.
• Labeler DUNS: 080254074
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-04-03
• Public Version: 4
• Public Version Date: 2020-04-20
• Public Version Status: Update
• Public Device Record Key: 95d7a0bc-56d9-4214-8dac-0cfab8e7fba3

Device Description

ELEOS™ STEM EXTENSION14X65MM STRAIGHT, FLUTED 14X65MM

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: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Radiation Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JWH	PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER	Orthopedic	888.3560	2

GMDN Terms

Code	Name	Definition	Implantable	Status
48066	Knee femur stem prosthesis	A sterile device designed to provide additional stability for an implanted knee femur prosthesis by extending the attachment of the prosthesis from the distal femur into the midshaft of the bone. It is typically a shaft-like device made of metal [e.g., cobalt-chrome (Co-Cr)] and is often used in prosthesis revision to compensate for bone loss.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B278KSC01465E0	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K161520	000