ECHO XL TiNano OLIF 108826120812

GUDID B521108826120812

ECHO XL TiNano OLIF 26mm X 12mm X 8 X 12mm

AURORA SPINE, INC.

Polymeric spinal fusion cage, sterile Polymeric spinal fusion cage, sterile

• Primary Device ID: B521108826120812
• NIH Device Record Key: fc970304-6189-4ca1-831d-87ed8a7e0799
• Commercial Distribution Discontinuation: 2019-02-01
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: ECHO XL TiNano OLIF
• Version Model Number: 108026120812
• Catalog Number: 108826120812
• Company DUNS: 079119091
• Company Name: AURORA SPINE, INC.
• 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

Customer Support Contacts

• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx

Device Dimensions

• Height: 12 Millimeter
• Angle: 8 degree
• Width: 12 Millimeter
• Length: 26 Millimeter
• Height: 12 Millimeter
• Angle: 8 degree
• Width: 12 Millimeter
• Length: 26 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B521108826120812 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133967

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-02-04
• Device Publish Date: 2017-02-01

On-Brand Devices [ECHO XL TiNano OLIF]

• B521108832120212: ECHO XL TiNano OLIF 32mm X 12mm X 2 X 12mm, CAGE, PEEK-TI CP
• B521108826120812: ECHO XL TiNano OLIF 26mm X 12mm X 8 X 12mm