Statyx™

GUDID M711AXT1430140

AxT, 14H x 30W x 14°, Ti 6Al 4V (ELI)

INNO Holdings, Inc.

Metallic spinal interbody fusion cage

• Primary Device ID: M711AXT1430140
• NIH Device Record Key: dcf05aa7-428b-4bca-9a06-bd933d239115
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Statyx™
• Version Model Number: AXT143014
• 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: 8012612236
• Email: info@innovasis.com
• Phone: 8012612236
• Email: info@innovasis.com
• Phone: 8012612236
• Email: info@innovasis.com
• Phone: 8012612236
• Email: info@innovasis.com
• Phone: 8012612236
• Email: info@innovasis.com
• Phone: 8012612236
• Email: info@innovasis.com

Device Dimensions

• Height: 14 Millimeter
• Width: 30 Millimeter
• Angle: 14 degree
• Height: 14 Millimeter
• Width: 30 Millimeter
• Angle: 14 degree
• Height: 14 Millimeter
• Width: 30 Millimeter
• Angle: 14 degree
• Height: 14 Millimeter
• Width: 30 Millimeter
• Angle: 14 degree
• Height: 14 Millimeter
• Width: 30 Millimeter
• Angle: 14 degree
• Height: 14 Millimeter
• Width: 30 Millimeter
• Angle: 14 degree

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M711AXT1430140 [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

[M711AXT1430140]

Moist Heat or Steam Sterilization

[M711AXT1430140]

Moist Heat or Steam Sterilization

[M711AXT1430140]

Moist Heat or Steam Sterilization

[M711AXT1430140]

Moist Heat or Steam Sterilization

[M711AXT1430140]

Moist Heat or Steam Sterilization

[M711AXT1430140]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2025-12-17
• Device Publish Date: 2025-09-30

On-Brand Devices [Statyx™]

• M711AXT2040200: AxT, 20H x 40W x 20°, Ti 6Al 4V (ELI)
• M711AXT2040140: AxT, 20H x 40W x 14°, Ti 6Al 4V (ELI)
• M711AXT2040080: AxT, 20H x 40W x 8°, Ti 6Al 4V (ELI)
• M711AXT2036200: AxT, 20H x 36W x 20°, Ti 6Al 4V (ELI)
• M711AXT2036140: AxT, 20H x 36W x 14°, Ti 6Al 4V (ELI)
• M711AXT2036080: AxT, 20H x 36W x 8°, Ti 6Al 4V (ELI)
• M711AXT2030300: AxT, 20H x 30W x 30°, Ti 6Al 4V (ELI)
• M711AXT2030200: AxT, 20H X 30W x 20°, Ti 6Al 4V (ELI)
• M711AXT2030140: AxT, 20H x 30W x 14°, Ti 6Al 4V (ELI)
• M711AXT2030080: AxT, 20H x 30W x 8°, Ti 6Al 4V (ELI),
• M711AXT1840200: AxT, 18H x 40W x 20°, Ti 6Al 4V (ELI)
• M711AXT1840140: AxT, 18H x 40W x 14°, Ti 6Al 4V (ELI)
• M711AXT1840080: AxT, 18H x 40W x 8°, Ti 6Al 4V (ELI)
• M711AXT1836200: AxT, 18H x 36W x 20°, Ti 6Al 4V (ELI)
• M711AXT1836140: AxT, 18H x 36W x 14°, Ti 6Al 4V (ELI)
• M711AXT1836080: AxT, 18H X 36W X 8°, Ti 6Al 4V (ELI)
• M711AXT1830300: AxT, 18H X 30W x 30°, Ti 6Al 4V (ELI)
• M711AXT1830200: AxT, 18H x 30W x 20°, Ti 6Al 4V (ELI)
• M711AXT1830140: AxT, 18H x 30W x 14°, Ti 6Al 4V (ELI)
• M711AXT1830080: AxT, 18H x 30W x 8°, Ti 6Al 4V (ELI)
• M711AXT1640140: AxT, 16H x 40W x 14°, Ti 6Al 4V (ELI)
• M711AXT1640080: AxT, 16H x 40W x 8°, Ti 6Al 4V (ELI)
• M711AXT1636200: AxT, 16H x 36W x 20°, Ti 6Al 4V (ELI)
• M711AXT1636140: AxT, 16H x 36W x 14°, Ti 6Al 4V (ELI)
• M711AXT1636080: AxT, 16H x 36W x 8°, Ti 6Al 4V (ELI)
• M711AXT1630200: AxT, 16H X 30W X 20°, Ti 6Al 4V (ELI)
• M711AXT1630140: AxT, 16H x 30W x 14°, Ti 6Al 4V (ELI)
• M711AXT1630080: AxT, 16H x 30W x 8°, Ti 6Al 4V (ELI)
• M711AXT1440140: AxT, 14H x 40W x 14°, Ti 6Al 4V (ELI)
• M711AXT1440080: AxT, 14H x 40W x 8°, Ti 6Al 4V (ELI)
• M711AXT1436140: AxT, 14H x 36W x 14°, Ti 6Al 4V (ELI)
• M711AXT1436080: AxT, 14H X 36W x 8°, Ti 6Al 4V (ELI)
• M711AXT1430200: AxT, 14H x 30W x 20°, Ti 6Al 4V (ELI)
• M711AXT1430140: AxT, 14H x 30W x 14°, Ti 6Al 4V (ELI)
• M711AXT1430080: AxT, 14H X 30W x 8°, Ti 6Al 4V (ELI)
• M711AXT1240140: AxT, 12H x 40W x 14°, Ti 6Al 4V (ELI)
• M711AXT1240080: AxT, 12H x 40W x 8°, Ti 6Al 4V (ELI)
• M711AXT1236140: AxT, 12H x 36W x 14°, Ti 6Al 4V (ELI)
• M711AXT1236080: AxT, 12H x 36W x 8°, Ti 6Al 4V (ELI)
• M711AXT1230140: AxT, 12H X 30W x 14°, Ti 6Al 4V (ELI)
• M711AXT1230080: AxT, 12H x 30W x 8°, Ti 6Al 4V (ELI)
• M711AXT1040080: AxT, 10H x 40W x 8°, Ti 6Al 4V (ELI)
• M711AXT1036080: AxT, 10H x 36W x 8°, Ti 6Al 4V (ELI)
• M711AXT1030140: AxT, 10H x 30W x 14°, Ti 6Al 4V (ELI)
• M711AXT1030080: AxT, 10H x 30W x 8°, Ti 6Al 4V (ELI),