F3D Sure Size Cervical Cage

GUDID M7253CZ18

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

CORELINK LLC

Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage

• Primary Device ID: M7253CZ18
• NIH Device Record Key: 08e40378-1ba5-4181-ae1d-add78c1a3891
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: F3D Sure Size Cervical Cage
• Version Model Number: 3CZLLWW-LLHH
• 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: false
• 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	M7253CZ18 [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 Sure Size Cervical Cage]

• M7253CZ18: F3D Sure Size Cervical Cage LL-Length, WW-Width, LL-Lordosis, HH-Height
• M7253CZ16: F3D Sure Size Cervical Cage LL-Length, WW-Width, LL-Lordosis, HH-Height
• M7253CZ14: F3D Sure Size Cervical Cage LL-Length, WW-Width, LL-Lordosis, HH-Height