Canturio® Smart Extension 14mm (D) x 30mm (H)

Basic Information

• Brand Name: Canturio® Smart Extension 14mm (D) x 30mm (H)
• Primary DI: 00860003118399
• Version / Model: 43-5570-030-14
• Company Name: Canary Medical USA LLC
• Labeler DUNS: 117153396
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-09-12
• Public Version: 1
• Public Version Date: 2024-09-20
• Public Version Status: New
• Public Device Record Key: 0eca5bb3-7e1c-4058-b18a-1795eca29ee1

Device Description

Canturio® Smart Extension 14mm (D) x 30mm (H) with Canary Health Implanted Reporting Processor (CHIRP®) system is a tibial extension implant containing electronics and software.

Device Characteristics

• Single Use: No
• 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: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QPP	Implantable Post-Surgical Kinematic Measurement Knee Device	Orthopedic	888.3600	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	00860003118399	GS1

Premarket Submissions

Submission Number	Supplement Number
K234056	000