Excella®-M

GUDID M711LA170010

SST

Innovasis, Inc.

Orthopaedic counter-torque/rod-pushing instrument Orthopaedic counter-torque/rod-pushing instrument Orthopaedic counter-torque/rod-pushing instrument Orthopaedic counter-torque/rod-pushing instrument Orthopaedic counter-torque/rod-pushing instrument Orthopaedic counter-torque/rod-pushing instrument Orthopaedic counter-torque/rod-pushing instrument Orthopaedic counter-torque/rod-pushing instrument Orthopaedic counter-torque/rod-pushing instrument Orthopaedic counter-torque/rod-pushing instrument Orthopaedic counter-torque/rod-pushing instrument Orthopaedic counter-torque/rod-pushing instrument Orthopaedic counter-torque/rod-pushing instrument Orthopaedic counter-torque/rod-pushing instrument Orthopaedic counter-torque/rod-pushing instrument Orthopaedic counter-torque/rod-pushing instrument

• Primary Device ID: M711LA170010
• NIH Device Record Key: f704c880-0a41-4a3e-8449-aab817a51020
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Excella®-M
• Version Model Number: LA-170-01
• Company DUNS: 156567492
• Company Name: Innovasis, 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: 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
• 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	M711LA170010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042143

FDA Product Code

• KWQ: Appliance, Fixation, Spinal Intervertebral Body

Sterilization

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

[M711LA170010]

Moist Heat or Steam Sterilization

[M711LA170010]

Moist Heat or Steam Sterilization

[M711LA170010]

Moist Heat or Steam Sterilization

[M711LA170010]

Moist Heat or Steam Sterilization

[M711LA170010]

Moist Heat or Steam Sterilization

[M711LA170010]

Moist Heat or Steam Sterilization

[M711LA170010]

Moist Heat or Steam Sterilization

[M711LA170010]

Moist Heat or Steam Sterilization

[M711LA170010]

Moist Heat or Steam Sterilization

[M711LA170010]

Moist Heat or Steam Sterilization

[M711LA170010]

Moist Heat or Steam Sterilization

[M711LA170010]

Moist Heat or Steam Sterilization

[M711LA170010]

Moist Heat or Steam Sterilization

[M711LA170010]

Moist Heat or Steam Sterilization

[M711LA170010]

Moist Heat or Steam Sterilization

[M711LA170010]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-04-08
• Device Publish Date: 2022-03-31

On-Brand Devices [Excella®-M]

• M711LA170010: SST
• M711BPS020: Al, SST
• M711BPS010: Al, SST