AxHA®

GUDID M711AX55300

Ti 6Al 4V (ELI)

Innovasis, Inc.

Metal-polymer composite spinal interbody fusion cage

• Primary Device ID: M711AX55300
• NIH Device Record Key: 29e9bede-38b4-4b11-91d1-a8b2cdfff6a2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AxHA®
• Version Model Number: AX5530
• Company DUNS: 156567492
• Company Name: Innovasis, Inc.
• Device Count: 1
• DM Exempt: true
• 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: 8012612236
• Email: info@innovasis.com

Device Dimensions

• Outer Diameter: 5.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M711AX55300 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162236

FDA Product Code

• OVD: Intervertebral Fusion Device With Integrated Fixation, Lumbar

Sterilization

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

[M711AX55300]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2020-02-24
• Device Publish Date: 2017-05-02

On-Brand Devices [AxHA®]

• M711AX55300: Ti 6Al 4V (ELI)
• M711AX55250: Ti 6Al 4V (ELI)
• M711AX55200: Ti 6Al 4V (ELI)
• M711AX2040301: HA PEEK, Tantalum, Ti 6Al 4V ELI
• M711AX2040201: HA PEEK, Tantalum, Ti 6Al 4V ELI
• M711AX2040141: HA PEEK, Tantalum, Ti 6Al 4V ELI
• M711AX2040081: HA PEEK, Tantalum, Ti 6Al 4V ELI
• M711AX2036301: HA PEEK, Tantalum, Ti 6Al 4V ELI
• M711AX2036201: HA PEEK, Tantalum, Ti 6Al 4V ELI
• M711AX2036141: HA PEEK, Tantalum, Ti 6Al 4V ELI
• M711AX2036081: HA PEEK, Tantalum, Ti 6Al 4V ELI
• M711AX2030301: HA PEEK, Tantalum, Ti 6Al 4V ELI
• M711AX2030201: HA PEEK, Tantalum, Ti 6Al 4V ELI
• M711AX2030141: HA PEEK, Tantalum, Ti 6Al 4V ELI
• M711AX2030081: HA PEEK, Tantalum, Ti 6Al 4V ELI
• M711AX1840201: HA PEEK, Tantalum, Ti 6Al 4V ELI
• M711AX1840141: HA PEEK, Tantalum, Ti 6Al 4V ELI
• M711AX1840081: HA PEEK, Tantalum, Ti 6Al 4V ELI
• M711AX1836301: HA PEEK, Tantalum, Ti 6Al 4V ELI
• M711AX1836201: HA PEEK, Tantalum, Ti 6Al 4V ELI
• M711AX1836141: HA PEEK, Tantalum, Ti 6Al 4V ELI
• M711AX1836081: HA PEEK, Tantalum, Ti 6Al 4V ELI
• M711AX1830301: HA PEEK, Tantalum, Ti 6Al 4V ELI
• M711AX1830201: HA PEEK, Tantalum, Ti 6Al 4V ELI
• M711AX1830141: HA PEEK, Tantalum, Ti 6Al 4V ELI
• M711AX1830081: HA PEEK, Tantalum, Ti 6Al 4V ELI
• M711AX1640201: HA PEEK, Tantalum, Ti 6Al 4V ELI
• M711AX1640141: HA PEEK, Tantalum, Ti 6Al 4V ELI
• M711AX1640081: HA PEEK, Tantalum, Ti 6Al 4V ELI
• M711AX1636201: HA PEEK, Tantalum, Ti 6Al 4V ELI
• M711AX1636141: HA PEEK, Tantalum, Ti 6Al 4V ELI
• M711AX1636081: HA PEEK, Tantalum, Ti 6Al 4V ELI
• M711AX1630301: HA PEEK, Tantalum, Ti 6Al 4V ELI
• M711AX1630201: HA PEEK, Tantalum, Ti 6Al 4V ELI
• M711AX1630141: HA PEEK, Tantalum, Ti 6Al 4V ELI
• M711AX1630081: HA PEEK, Tantalum, Ti 6Al 4V ELI
• M711AX1440141: HA PEEK, Tantalum, Ti 6Al 4V ELI
• M711AX1440081: HA PEEK, Tantalum, Ti 6Al 4V ELI
• M711AX1436201: HA PEEK, Tantalum, Ti 6Al 4V ELI
• M711AX1436141: HA PEEK, Tantalum, Ti 6Al 4V ELI
• M711AX1436081: HA PEEK, Tantalum, Ti 6Al 4V ELI
• M711AX1430201: HA PEEK, Tantalum, Ti 6Al 4V ELI
• M711AX1430141: HA PEEK, Tantalum, Ti 6Al 4V ELI
• M711AX1430081: HA PEEK, Tantalum, Ti 6Al 4V ELI
• M711AX1240141: HA PEEK, Tantalum, Ti 6Al 4V ELI
• M711AX1240081: HA PEEK, Tantalum, Ti 6Al 4V ELI
• M711AX1236141: HA PEEK, Tantalum, Ti 6Al 4V ELI
• M711AX1236081: HA PEEK, Tantalum, Ti 6Al 4V ELI
• M711AX1230201: HA PEEK, Tantalum, Ti 6Al 4V ELI
• M711AX1230141: HA PEEK, Tantalum, Ti 6Al 4V ELI