AxTiHA

GUDID M71164010

Ti 6Al 4V (ELI)

INNO Holdings, Inc.

Metallic spinal interbody fusion cage

• Primary Device ID: M71164010
• NIH Device Record Key: a01fc28e-c241-4890-b411-41bb518d8a02
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AxTiHA
• Version Model Number: 64-01
• Company DUNS: 141620464
• Company Name: INNO Holdings, 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

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M71164010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212967

FDA Product Code

• OVD: Intervertebral Fusion Device With Integrated Fixation, Lumbar

Sterilization

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

[M71164010]

Moist Heat or Steam Sterilization

[M71164010]

Moist Heat or Steam Sterilization

[M71164010]

Moist Heat or Steam Sterilization

[M71164010]

Moist Heat or Steam Sterilization

[M71164010]

Moist Heat or Steam Sterilization

[M71164010]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2025-12-17
• Device Publish Date: 2022-01-06

On-Brand Devices [AxTiHA]

• M71164020: Ti 6Al 4V (ELI)
• M71164010: Ti 6Al 4V (ELI)