KeyFix Bone Cement Filler Cannula

Basic Information

• Brand Name: KeyFix Bone Cement Filler Cannula
• Primary DI: 08058964724083
• Version / Model: 900100
• Company Name: G21 SRL
• Labeler DUNS: 431529195
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-10-10
• Public Version: 1
• Public Version Date: 2024-10-18
• Public Version Status: New
• Public Device Record Key: 3866feb6-d35b-4829-9e50-f16dec001112

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: Yes
• 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
OCJ	Spinal Channeling Instrument, Vertebroplasty	Orthopedic	888.4540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58032	Vertebral body cement cannula	A sterile, manual, tubular device designed to create a percutaneous access channel into a vertebral body prior to and during injection of orthopaedic cement into the vertebral body during kyphoplasty. It is typically inserted under fluoroscopic guidance to treat a patient diagnosed with vertebral compression fractures (VCFs) in the lumbar or thoracic region of the spine. The device is typically made of stainless steel with an attached plastic handle and available in a kit of several equal size cannulae (e.g., 3 or 6) to provide access to one or more sites of intervention. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08058964724083	GS1