Excella 3™ E3N8540

GUDID M711E3N85400

Ti 6Al 4V (ELI)

Innovasis, Inc.

Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable

• Primary Device ID: M711E3N85400
• NIH Device Record Key: ce6388b5-ee54-42b1-bae2-d427215a2800
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Excella 3™
• Version Model Number: E3N8540
• Catalog Number: E3N8540
• 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

• Outer Diameter: 8.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 40 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M711E3N85400 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102248

FDA Product Code

• NKB: Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease

Sterilization

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

[M711E3N85400]

Moist Heat or Steam Sterilization

[M711E3N85400]

Moist Heat or Steam Sterilization

[M711E3N85400]

Moist Heat or Steam Sterilization

[M711E3N85400]

Moist Heat or Steam Sterilization

[M711E3N85400]

Moist Heat or Steam Sterilization

[M711E3N85400]

Moist Heat or Steam Sterilization

[M711E3N85400]

Moist Heat or Steam Sterilization

[M711E3N85400]

Moist Heat or Steam Sterilization

[M711E3N85400]

Moist Heat or Steam Sterilization

[M711E3N85400]

Moist Heat or Steam Sterilization

[M711E3N85400]

Moist Heat or Steam Sterilization

[M711E3N85400]

Moist Heat or Steam Sterilization

[M711E3N85400]

Moist Heat or Steam Sterilization

[M711E3N85400]

Moist Heat or Steam Sterilization

[M711E3N85400]

Moist Heat or Steam Sterilization

[M711E3N85400]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2024-05-21
• Device Publish Date: 2017-11-17

On-Brand Devices [Excella 3™]

• M711BTA1470: Al, SST, Nylon, Silicone
• M711BTA1480: Al, SST, Silicone
• M711BTA660: Al, SST, Nylon, Silicone
• M711BTA640: Al, SST, Silicone
• M711E3N85600: Ti 6Al 4V (ELI)
• M711E3N85550: Ti 6Al 4V (ELI)
• M711E3N85500: Ti 6Al 4V (ELI)
• M711E3N85450: Ti 6Al 4V (ELI)
• M711E3N85400: Ti 6Al 4V (ELI)
• M711E3N85350: Ti 6Al 4V (ELI)
• M711E3N85300: Ti 6Al 4V (ELI)
• M711E3N75600: Ti 6Al 4V (ELI)
• M711E3N75550: Ti 6Al 4V (ELI)
• M711E3N75500: Ti 6Al 4V (ELI)
• M711E3N75450: Ti 6Al 4V (ELI)
• M711E3N75400: Ti 6Al 4V (ELI)
• M711E3N75350: Ti 6Al 4V (ELI)
• M711E3N75300: Ti 6Al 4V (ELI)
• M711E3N65600: Ti 6Al 4V (ELI)
• M711E3N65550: Ti 6Al 4V (ELI)
• M711E3N65500: Ti 6Al 4V (ELI)
• M711E3N65450: Ti 6Al 4V (ELI)
• M711E3N65400: Ti 6Al 4V (ELI)
• M711E3N65350: Ti 6Al 4V (ELI)
• M711E3N65300: Ti 6Al 4V (ELI)
• M711E3N65250: Ti 6Al 4V (ELI)
• M711E3N55550: Ti 6Al 4V (ELI)
• M711E3N55500: Ti 6Al 4V (ELI)
• M711E3N55450: Ti 6Al 4V (ELI)
• M711E3N55400: Ti 6Al 4V (ELI)
• M711E3N55350: Ti 6Al 4V (ELI)
• M711E3N55300: Ti 6Al 4V (ELI)
• M711E3N55250: Ti 6Al 4V (ELI)
• M711E3N475450: Ti 6Al 4V (ELI)
• M711E3N475400: Ti 6Al 4V (ELI)
• M711E3N475350: Ti 6Al 4V (ELI)
• M711E3N475300: Ti 6Al 4V (ELI)
• M711E3N475250: Ti 6Al 4V (ELI)