Tx™ LS-397-1510

GUDID M711LS39715100

Ti 6Al 4V (ELI)

INNO Holdings, Inc.

Spinal implant trial

• Primary Device ID: M711LS39715100
• NIH Device Record Key: 8e2472df-cf5f-41bb-ba8c-40e234af9cd1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tx™
• Version Model Number: LS-397-1510
• Catalog Number: LS-397-1510
• Company DUNS: 141620464
• Company Name: INNO Holdings, 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: false
• Lot Batch: false
• Serial Number: true
• 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

Device Dimensions

• Angle: 10 degree
• Length: 28 Millimeter
• Height: 15 Millimeter
• Width: 10 Millimeter
• Angle: 10 degree
• Length: 28 Millimeter
• Height: 15 Millimeter
• Width: 10 Millimeter
• Angle: 10 degree
• Length: 28 Millimeter
• Height: 15 Millimeter
• Width: 10 Millimeter
• Angle: 10 degree
• Length: 28 Millimeter
• Height: 15 Millimeter
• Width: 10 Millimeter
• Angle: 10 degree
• Length: 28 Millimeter
• Height: 15 Millimeter
• Width: 10 Millimeter
• Angle: 10 degree
• Length: 28 Millimeter
• Height: 15 Millimeter
• Width: 10 Millimeter
• Angle: 10 degree
• Length: 28 Millimeter
• Height: 15 Millimeter
• Width: 10 Millimeter
• Angle: 10 degree
• Length: 28 Millimeter
• Height: 15 Millimeter
• Width: 10 Millimeter
• Angle: 10 degree
• Length: 28 Millimeter
• Height: 15 Millimeter
• Width: 10 Millimeter
• Angle: 10 degree
• Length: 28 Millimeter
• Height: 15 Millimeter
• Width: 10 Millimeter
• Angle: 10 degree
• Length: 28 Millimeter
• Height: 15 Millimeter
• Width: 10 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M711LS39715100 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180078

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

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

[M711LS39715100]

Moist Heat or Steam Sterilization

[M711LS39715100]

Moist Heat or Steam Sterilization

[M711LS39715100]

Moist Heat or Steam Sterilization

[M711LS39715100]

Moist Heat or Steam Sterilization

[M711LS39715100]

Moist Heat or Steam Sterilization

[M711LS39715100]

Moist Heat or Steam Sterilization

[M711LS39715100]

Moist Heat or Steam Sterilization

[M711LS39715100]

Moist Heat or Steam Sterilization

[M711LS39715100]

Moist Heat or Steam Sterilization

[M711LS39715100]

Moist Heat or Steam Sterilization

[M711LS39715100]

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: 2018-08-14

On-Brand Devices [Tx™]

• M711TX121633121: HA PEEK, Ta
• M711TX101428101: HA PEEK, Ta
• M711LS43316120: Ti 6Al 4V (ELI)
• M711LS43316100: Ti 6Al 4V (ELI)
• M711LS43316050: Ti 6Al 4V (ELI)
• M711LS43315120: Ti 6Al 4V (ELI)
• M711LS43315100: Ti 6Al 4V (ELI)
• M711LS43315050: Ti 6Al 4V (ELI)
• M711LS43314120: Ti 6Al 4V (ELI)
• M711LS43314100: Ti 6Al 4V (ELI)
• M711LS43314050: Ti 6Al 4V (ELI)
• M711LS43313120: Ti 6Al 4V (ELI)
• M711LS43313100: Ti 6Al 4V (ELI)
• M711LS43313050: Ti 6Al 4V (ELI)
• M711LS43312120: Ti 6Al 4V (ELI)
• M711LS43312100: Ti 6Al 4V (ELI)
• M711LS43312050: Ti 6Al 4V (ELI)
• M711LS43311120: Ti 6Al 4V (ELI)
• M711LS43311100: Ti 6Al 4V (ELI)
• M711LS43311050: Ti 6Al 4V (ELI)
• M711LS43310120: Ti 6Al 4V (ELI)
• M711LS43310100: Ti 6Al 4V (ELI)
• M711LS43310050: Ti 6Al 4V (ELI)
• M711LS43309120: Ti 6Al 4V (ELI)
• M711LS43309100: Ti 6Al 4V (ELI)
• M711LS43309050: Ti 6Al 4V (ELI)
• M711LS43308050: Ti 6Al 4V (ELI)
• M711LS39716120: Ti 6Al 4V (ELI)
• M711LS39716100: Ti 6Al 4V (ELI)
• M711LS39716050: Ti 6Al 4V (ELI)
• M711LS39715120: Ti 6Al 4V (ELI)
• M711LS39715100: Ti 6Al 4V (ELI)
• M711LS39715050: Ti 6Al 4V (ELI)
• M711LS39714120: Ti 6Al 4V (ELI)
• M711LS39714100: Ti 6Al 4V (ELI)
• M711LS39714050: Ti 6Al 4V (ELI)
• M711LS39713120: Ti 6Al 4V (ELI)
• M711LS39713100: Ti 6Al 4V (ELI)
• M711LS39713050: Ti 6Al 4V (ELI)
• M711LS39712120: Ti 6Al 4V (ELI)
• M711LS39712100: Ti 6Al 4V (ELI)
• M711LS39712050: Ti 6Al 4V (ELI)
• M711LS39711120: Ti 6Al 4V (ELI)
• M711LS39711100: Ti 6Al 4V (ELI)
• M711LS39711050: Ti 6Al 4V (ELI)
• M711LS39710120: Ti 6Al 4V (ELI)
• M711LS39710100: Ti 6Al 4V (ELI)
• M711LS39710050: Ti 6Al 4V (ELI)
• M711LS39709120: Ti 6Al 4V (ELI)
• M711LS39709100: Ti 6Al 4V (ELI)