ECHO TiNano PLIF 108826100810

GUDID B521108826100810

ECHO TiNano PLIF 26mm X 10mm X 8 X 10mm

AURORA SPINE, INC.

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

• Primary Device ID: B521108826100810
• NIH Device Record Key: 3c8f7e17-cce2-4ecd-a617-53e2abd377ef
• Commercial Distribution Discontinuation: 2019-01-01
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: ECHO TiNano PLIF
• Version Model Number: 108026100810
• Catalog Number: 108826100810
• 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: 10 Millimeter
• Angle: 8 degree
• Width: 10 Millimeter
• Length: 26 Millimeter
• Height: 10 Millimeter
• Angle: 8 degree
• Width: 10 Millimeter
• Length: 26 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B521108826100810 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133967

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: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-01-29
• Device Publish Date: 2017-02-02

On-Brand Devices [ECHO TiNano PLIF]

• B521108826100810: ECHO TiNano PLIF 26mm X 10mm X 8 X 10mm
• B521108824080807: ECHO TiNano PLIF 24mm X 8mm X 8 X 7mm
• B521108822080812: ECHO TiNano PLIF 22mm X 8mm X 8 X 12mm
• B521108822080810: ECHO TiNano PLIF 22mm X 8mm X 8 X 10mm, CAGE, PEEK-TICP