F3D Cervical Cage

GUDID M7253CF14

F3D Cervical Cage LL-Length, WW-Width, LL-Lordosis, HH-Height

CORELINK LLC

Metallic spinal interbody fusion cage

• Primary Device ID: M7253CF14
• NIH Device Record Key: 9879cf88-1a14-4b41-a6cf-5a6a5ef1a457
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: F3D Cervical Cage
• Version Model Number: 3CFLLWWLLHH
• Company DUNS: 064191453
• Company Name: CORELINK LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M7253CF14 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162496

FDA Product Code

• ODP: Intervertebral Fusion Device With Bone Graft, Cervical

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-04-27
• Device Publish Date: 2022-04-19

On-Brand Devices [F3D Cervical Cage]

• M7253CF18: F3D Cervical Cage LL-Length, WW-Width, LL-Lordosis, HH-Height
• M7253CF16: F3D Cervical Cage LL-Length, WW-Width, LL-Lordosis, HH-Height
• M7253CF14: F3D Cervical Cage LL-Length, WW-Width, LL-Lordosis, HH-Height