Excella® LS-042

GUDID M711LS0420

SST

INNO Holdings, Inc.

Orthopaedic fixation implant alignment tool

• Primary Device ID: M711LS0420
• NIH Device Record Key: 441cdaa5-02e1-4078-accb-3f5677e22a52
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Excella®
• Version Model Number: LS-042
• Catalog Number: LS-042
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M711LS0420 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K071921

FDA Product Code

• MNH: Orthosis, Spondylolisthesis Spinal Fixation

Sterilization

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

[M711LS0420]

Moist Heat or Steam Sterilization

[M711LS0420]

Moist Heat or Steam Sterilization

[M711LS0420]

Moist Heat or Steam Sterilization

[M711LS0420]

Moist Heat or Steam Sterilization

[M711LS0420]

Moist Heat or Steam Sterilization

[M711LS0420]

Moist Heat or Steam Sterilization

[M711LS0420]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2025-12-17
• Device Publish Date: 2018-01-31

On-Brand Devices [Excella®]

• M711LS1260: SST
• M711LS1230: SST
• M711LS0710: SST
• M711LS0700: SST
• M711LS0650: Silicone, TiN, SST
• M711LS0420: SST
• M711LA1500: Silicone, SST