Excella MIS®

GUDID M711LS5680

Nitinol

Innovasis, Inc.

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• Primary Device ID: M711LS5680
• NIH Device Record Key: 8b10d85e-f43b-42d5-ae19-422d30800ae3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Excella MIS®
• Version Model Number: LS-568
• Company DUNS: 156567492
• Company Name: Innovasis, 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: 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
• 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

• Length: 500 Millimeter
• Outer Diameter: 1.4 Millimeter
• Length: 500 Millimeter
• Outer Diameter: 1.4 Millimeter
• Length: 500 Millimeter
• Outer Diameter: 1.4 Millimeter
• Length: 500 Millimeter
• Outer Diameter: 1.4 Millimeter
• Length: 500 Millimeter
• Outer Diameter: 1.4 Millimeter
• Length: 500 Millimeter
• Outer Diameter: 1.4 Millimeter
• Length: 500 Millimeter
• Outer Diameter: 1.4 Millimeter
• Length: 500 Millimeter
• Outer Diameter: 1.4 Millimeter
• Length: 500 Millimeter
• Outer Diameter: 1.4 Millimeter
• Length: 500 Millimeter
• Outer Diameter: 1.4 Millimeter
• Length: 500 Millimeter
• Outer Diameter: 1.4 Millimeter
• Length: 500 Millimeter
• Outer Diameter: 1.4 Millimeter
• Length: 500 Millimeter
• Outer Diameter: 1.4 Millimeter
• Length: 500 Millimeter
• Outer Diameter: 1.4 Millimeter
• Length: 500 Millimeter
• Outer Diameter: 1.4 Millimeter
• Length: 500 Millimeter
• Outer Diameter: 1.4 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M711LS5680 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102248

FDA Product Code

• NKB: Thoracolumbosacral Pedicle Screw System

Sterilization

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

[M711LS5680]

Moist Heat or Steam Sterilization

[M711LS5680]

Moist Heat or Steam Sterilization

[M711LS5680]

Moist Heat or Steam Sterilization

[M711LS5680]

Moist Heat or Steam Sterilization

[M711LS5680]

Moist Heat or Steam Sterilization

[M711LS5680]

Moist Heat or Steam Sterilization

[M711LS5680]

Moist Heat or Steam Sterilization

[M711LS5680]

Moist Heat or Steam Sterilization

[M711LS5680]

Moist Heat or Steam Sterilization

[M711LS5680]

Moist Heat or Steam Sterilization

[M711LS5680]

Moist Heat or Steam Sterilization

[M711LS5680]

Moist Heat or Steam Sterilization

[M711LS5680]

Moist Heat or Steam Sterilization

[M711LS5680]

Moist Heat or Steam Sterilization

[M711LS5680]

Moist Heat or Steam Sterilization

[M711LS5680]

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 MIS®]

• M711LS3510: Nitinol
• M711BTA1030: Al, SST, Nylon, Silicone
• M711BTA750: Polypropylene, Radel, SST
• M711BTA740: Polypropylene, Radel, SST
• M711BTA730: Polypropylene, Radel, SST
• M711BTA720: Polypropylene, Radel, SST
• M711BTA710: Polypropylene, Radel, SST
• M711BTA1630: Polypropylene, Radel
• M711BTA1090: Al, SST, Polypropylene, Nylon
• M711LS5680: Nitinol
• M711LS5670: Nitinol
• M711LS5640: Nitinol
• M711LS5630: Nitinol
• M711BTA880: Al, SST, Nylon, Silicone
• M711BTA870: Al, SST, Nylon, Silicone
• M711LS2180: Al, Silicone, SST
• M711LS2120: Nitinol
• M711LS2080: Ti 6Al 4V (ELI)
• M711LS1940: Al, Silicone, SST
• M711LS1930: Al, Silicone, SST
• M711LS1890: Nitinol
• M711EM75600: Ti 6Al 4V (ELI)
• M711EM75550: Ti 6Al 4V (ELI)
• M711EM75500: Ti 6Al 4V (ELI)
• M711EM75450: Ti 6Al 4V (ELI)
• M711EM75400: Ti 6Al 4V (ELI)
• M711EM75350: Ti 6Al 4V (ELI)
• M711EM75300: Ti 6Al 4V (ELI)
• M711EM65600: Ti 6Al 4V (ELI)
• M711EM65550: Ti 6Al 4V (ELI)
• M711EM65500: Ti 6Al 4V (ELI)
• M711EM65450: Ti 6Al 4V (ELI)
• M711EM65400: Ti 6Al 4V (ELI)
• M711EM65350: Ti 6Al 4V (ELI)
• M711EM65300: Ti 6Al 4V (ELI)
• M711EM65250: Ti 6Al 4V (ELI)
• M711EM55550: Ti 6Al 4V (ELI)
• M711EM55500: Ti 6Al 4V (ELI)
• M711EM55450: Ti 6Al 4V (ELI)
• M711EM55400: Ti 6Al 4V (ELI)
• M711EM55350: Ti 6Al 4V (ELI)
• M711EM55300: Ti 6Al 4V (ELI)
• M711EM475450: Ti 6Al 4V (ELI)
• M711EM475400: Ti 6Al 4V (ELI)
• M711EM475350: Ti 6Al 4V (ELI)
• M711EM475300: Ti 6Al 4V (ELI)
• M711EM475250: Ti 6Al 4V (ELI)
• M711MSR552000: Ti 6Al 4V (ELI)
• M711MSR551900: Ti 6Al 4V (ELI)
• M711MSR551800: Ti 6Al 4V (ELI)