CORI

Basic Information

• Brand Name: CORI
• Primary DI: 00885556809655
• Version / Model: ROB10101
• Catalog Number: ROB10101
• Company Name: Smith & Nephew, Inc.
• Labeler DUNS: 045483575
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-14
• Public Version: 2
• Public Version Date: 2023-09-07
• Public Version Status: Update
• Public Device Record Key: 9e778c54-83dc-4fc9-90a2-6d4c71bec087

Device Description

CORI KNEE TENSIONER CARTRIDGE

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: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OLO	Orthopedic stereotaxic instrument	Neurology	882.4560	2

GMDN Terms

Code	Name	Definition	Implantable	Status
66421	Orthopaedic knee-balance analyser electrical cable/analogue-to-digital converter	A non-patient-contact electrical cord with integrated circuit board and software intended to interface between an electrically-powered orthopaedic knee-balance analyser and a computing device during a total knee arthroplasty (TKA) to: 1) transmit electrical power to the analyser; and 2) convert the analyser analogue data signal to digital for transmission to the computing device for display. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00885556809655	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K221224	000