DISCOVERY TiNano ACIF 105010508

GUDID B521105010508

DISCOVERY TiNano ACIF 14mm X 16mm X 5 X 8mm

AURORA SPINE, INC.

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

• Primary Device ID: B521105010508
• NIH Device Record Key: 9d29a9b2-0e56-4cbb-9612-4e97ba122d9b
• Commercial Distribution Discontinuation: 2019-02-01
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: DISCOVERY TiNano ACIF
• Version Model Number: 105010508
• Catalog Number: 105010508
• 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: 8 Millimeter
• Angle: 5 degree
• Width: 16 Millimeter
• Length: 14 Millimeter
• Height: 8 Millimeter
• Angle: 5 degree
• Width: 16 Millimeter
• Length: 14 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B521105010508 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111484

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: 2019-02-04
• Device Publish Date: 2017-02-02

On-Brand Devices [DISCOVERY TiNano ACIF]

• B521105010509: DISCOVERY TiNano ACIF 14mm X 16mm X 5 9mm
• B521105010508: DISCOVERY TiNano ACIF 14mm X 16mm X 5 X 8mm
• B521105010507: DISCOVERY TiNano ACIF 14mm X 16mm X 5 X 7
• B521105010505: DISCOVERY TiNano ACIF 14mm X 16mm X 5 X 5mm