LxHA™ LXT22123508

GUDID M711LXT221235081

HA PEEK, Ta

INNO Holdings, Inc.

Polymeric spinal interbody fusion cage

• Primary Device ID: M711LXT221235081
• NIH Device Record Key: b7f3a36d-4c07-42ce-996b-633f64b3a49f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LxHA™
• Version Model Number: LXT22123508
• Catalog Number: LXT22123508
• 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
• 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

• Width: 22 Millimeter
• Height: 12 Millimeter
• Length: 35 Millimeter
• Angle: 8 degree
• Width: 22 Millimeter
• Height: 12 Millimeter
• Length: 35 Millimeter
• Angle: 8 degree
• Width: 22 Millimeter
• Height: 12 Millimeter
• Length: 35 Millimeter
• Angle: 8 degree
• Width: 22 Millimeter
• Height: 12 Millimeter
• Length: 35 Millimeter
• Angle: 8 degree
• Width: 22 Millimeter
• Height: 12 Millimeter
• Length: 35 Millimeter
• Angle: 8 degree
• Width: 22 Millimeter
• Height: 12 Millimeter
• Length: 35 Millimeter
• Angle: 8 degree
• Width: 22 Millimeter
• Height: 12 Millimeter
• Length: 35 Millimeter
• Angle: 8 degree
• Width: 22 Millimeter
• Height: 12 Millimeter
• Length: 35 Millimeter
• Angle: 8 degree
• Width: 22 Millimeter
• Height: 12 Millimeter
• Length: 35 Millimeter
• Angle: 8 degree
• Width: 22 Millimeter
• Height: 12 Millimeter
• Length: 35 Millimeter
• Angle: 8 degree
• Width: 22 Millimeter
• Height: 12 Millimeter
• Length: 35 Millimeter
• Angle: 8 degree
• Width: 22 Millimeter
• Height: 12 Millimeter
• Length: 35 Millimeter
• Angle: 8 degree

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M711LXT221235080 [Primary]
HIBCC	M711LXT221235081 [Package]; Contains: M711LXT221235080; Package: Carton [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190684

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, 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: 3
• Public Version Date: 2025-12-17
• Device Publish Date: 2019-07-31

On-Brand Devices [LxHA™]

• M711LXT221235081: HA PEEK, Ta
• M711LXL261660001: HA PEEK, Ta
• M711LXL181250161: HA PEEK, Ta
• M711LXL181045121: HA PEEK, Ta
• M711LS5070: SST, Silicone, Al, Adhesive
• M711LS506180: Ti 6Al 4V (ELI)
• M711LS506170: Ti 6Al 4V (ELI)
• M711LS506160: Ti 6Al 4V (ELI)
• M711LS506150: Ti 6Al 4V (ELI)
• M711LS506140: Ti 6Al 4V (ELI)
• M711LS506130: Ti 6Al 4V (ELI)
• M711LS506120: Ti 6Al 4V (ELI)
• M711LS506110: Ti 6Al 4V (ELI)
• M711LS506100: Ti 6Al 4V (ELI)
• M711LS506090: Ti 6Al 4V (ELI)
• M711LS506080: Ti 6Al 4V (ELI)
• M711LS506070: Ti 6Al 4V (ELI)
• M711LS506060: Ti 6Al 4V (ELI)
• M711LS506050: Ti 6Al 4V (ELI)
• M711LS506040: Ti 6Al 4V (ELI)
• M711LS506030: Ti 6Al 4V (ELI)
• M711LS506020: Ti 6Al 4V (ELI)
• M711LS506010: Ti 6Al 4V (ELI)
• M711LS505200: Ti 6Al 4V (ELI)
• M711LS505190: Ti 6Al 4V (ELI)
• M711LS505180: Ti 6Al 4V (ELI)
• M711LS505170: Ti 6Al 4V (ELI)
• M711LS505160: Ti 6Al 4V (ELI)
• M711LS505150: Ti 6Al 4V (ELI)
• M711LS505140: Ti 6Al 4V (ELI)
• M711LS505130: Ti 6Al 4V (ELI)
• M711LS505120: Ti 6Al 4V (ELI)
• M711LS505110: Ti 6Al 4V (ELI)
• M711LS505100: Ti 6Al 4V (ELI)
• M711LS505090: Ti 6Al 4V (ELI)
• M711LS505080: Ti 6Al 4V (ELI)
• M711LS505070: Ti 6Al 4V (ELI)
• M711LS505060: Ti 6Al 4V (ELI)
• M711LS505050: Ti 6Al 4V (ELI)
• M711LS505040: Ti 6Al 4V (ELI)
• M711LS505030: Ti 6Al 4V (ELI)
• M711LS505020: Ti 6Al 4V (ELI)
• M711LS505010: Ti 6Al 4V (ELI)
• M711LS504210: Ti 6Al 4V (ELI)
• M711LS504200: Ti 6Al 4V (ELI)
• M711LS504190: Ti 6Al 4V (ELI)
• M711LS504180: Ti 6Al 4V (ELI)
• M711LS504170: Ti 6Al 4V (ELI)
• M711LS504160: Ti 6Al 4V (ELI)
• M711LS504150: Ti 6Al 4V (ELI)