AXTi™ AXTi163008

GUDID M711AXTI1630081

Ti 6Al 4V (ELI)

Innovasis, Inc.

Metallic spinal interbody fusion cage

• Primary Device ID: M711AXTI1630081
• NIH Device Record Key: 00ff7243-2233-4ad5-96f7-aab005558899
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AXTi™
• Version Model Number: AXTi163008
• Catalog Number: AXTi163008
• Company DUNS: 156567492
• Company Name: Innovasis, 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: false
• 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: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com

Device Dimensions

• Angle: 8 degree
• Height: 16 Millimeter
• Width: 30 Millimeter
• Angle: 8 degree
• Height: 16 Millimeter
• Width: 30 Millimeter
• Angle: 8 degree
• Height: 16 Millimeter
• Width: 30 Millimeter
• Angle: 8 degree
• Height: 16 Millimeter
• Width: 30 Millimeter
• Angle: 8 degree
• Height: 16 Millimeter
• Width: 30 Millimeter
• Angle: 8 degree
• Height: 16 Millimeter
• Width: 30 Millimeter
• Angle: 8 degree
• Height: 16 Millimeter
• Width: 30 Millimeter
• Angle: 8 degree
• Height: 16 Millimeter
• Width: 30 Millimeter
• Angle: 8 degree
• Height: 16 Millimeter
• Width: 30 Millimeter
• Angle: 8 degree
• Height: 16 Millimeter
• Width: 30 Millimeter
• Angle: 8 degree
• Height: 16 Millimeter
• Width: 30 Millimeter
• Angle: 8 degree
• Height: 16 Millimeter
• Width: 30 Millimeter
• Angle: 8 degree
• Height: 16 Millimeter
• Width: 30 Millimeter
• Angle: 8 degree
• Height: 16 Millimeter
• Width: 30 Millimeter
• Angle: 8 degree
• Height: 16 Millimeter
• Width: 30 Millimeter
• Angle: 8 degree
• Height: 16 Millimeter
• Width: 30 Millimeter
• Angle: 8 degree
• Height: 16 Millimeter
• Width: 30 Millimeter
• Angle: 8 degree
• Height: 16 Millimeter
• Width: 30 Millimeter
• Angle: 8 degree
• Height: 16 Millimeter
• Width: 30 Millimeter
• Angle: 8 degree
• Height: 16 Millimeter
• Width: 30 Millimeter
• Angle: 8 degree
• Height: 16 Millimeter
• Width: 30 Millimeter
• Angle: 8 degree
• Height: 16 Millimeter
• Width: 30 Millimeter
• Angle: 8 degree
• Height: 16 Millimeter
• Width: 30 Millimeter
• Angle: 8 degree
• Height: 16 Millimeter
• Width: 30 Millimeter
• Angle: 8 degree

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M711AXTI1630080 [Primary]
HIBCC	M711AXTI1630081 [Package]; Contains: M711AXTI1630080; Package: Carton [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182139

FDA Product Code

• OVD: Intervertebral Fusion Device With Integrated Fixation, 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: 2
• Public Version Date: 2020-02-24
• Device Publish Date: 2019-08-31

On-Brand Devices [AXTi™]

• M711AXTI2040301: Ti 6Al 4V (ELI)
• M711AXTI2040201: Ti 6Al 4V (ELI)
• M711AXTI2040141: Ti 6Al 4V (ELI)
• M711AXTI2040081: Ti 6Al 4V (ELI)
• M711AXTI2036301: Ti 6Al 4V (ELI)
• M711AXTI2036201: Ti 6Al 4V (ELI)
• M711AXTI2036141: Ti 6Al 4V (ELI)
• M711AXTI2036081: Ti 6Al 4V (ELI)
• M711AXTI2030301: Ti 6Al 4V (ELI)
• M711AXTI2030201: Ti 6Al 4V (ELI)
• M711AXTI2030141: Ti 6Al 4V (ELI)
• M711AXTI2030081: Ti 6Al 4V (ELI)
• M711AXTI1840201: Ti 6Al 4V (ELI)
• M711AXTI1840141: Ti 6Al 4V (ELI)
• M711AXTI1840081: Ti 6Al 4V (ELI)
• M711AXTI1836201: Ti 6Al 4V (ELI)
• M711AXTI1836141: Ti 6Al 4V (ELI)
• M711AXTI1836081: Ti 6Al 4V (ELI)
• M711AXTI1830301: Ti 6Al 4V (ELI)
• M711AXTI1830201: Ti 6Al 4V (ELI)
• M711AXTI1830141: Ti 6Al 4V (ELI)
• M711AXTI1830081: Ti 6Al 4V (ELI)
• M711AXTI1640201: Ti 6Al 4V (ELI)
• M711AXTI1640141: Ti 6Al 4V (ELI)
• M711AXTI1640081: Ti 6Al 4V (ELI)
• M711AXTI1636201: Ti 6Al 4V (ELI)
• M711AXTI1636141: Ti 6Al 4V (ELI)
• M711AXTI1636081: Ti 6Al 4V (ELI)
• M711AXTI1630301: Ti 6Al 4V (ELI)
• M711AXTI1630201: Ti 6Al 4V (ELI)
• M711AXTI1630141: Ti 6Al 4V (ELI)
• M711AXTI1630081: Ti 6Al 4V (ELI)
• M711AXTI1440141: Ti 6Al 4V (ELI)
• M711AXTI1440081: Ti 6Al 4V (ELI)
• M711AXTI1436141: Ti 6Al 4V (ELI)
• M711AXTI1436081: Ti 6Al 4V (ELI)
• M711AXTI1430201: Ti 6Al 4V (ELI)
• M711AXTI1430141: Ti 6Al 4V (ELI)
• M711AXTI1430081: Ti 6Al 4V (ELI)
• M711AXTI1240141: Ti 6Al 4V (ELI)
• M711AXTI1240081: Ti 6Al 4V (ELI)
• M711AXTI1236141: Ti 6Al 4V (ELI)
• M711AXTI1236081: Ti 6Al 4V (ELI)
• M711AXTI1230201: Ti 6Al 4V (ELI)
• M711AXTI1230141: Ti 6Al 4V (ELI)
• M711AXTI1230081: Ti 6Al 4V (ELI)
• M711AXTI1040081: Ti 6Al 4V (ELI)
• M711AXTI1036081: Ti 6Al 4V (ELI)
• M711AXTI1030141: Ti 6Al 4V (ELI)
• M711AXTI1030081: Ti 6Al 4V (ELI)