Excella 3® ECC6560

GUDID M711ECC65600

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: M711ECC65600
• NIH Device Record Key: b0f37770-d6b0-4e63-8d6b-8094e9f9a4d2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Excella 3®
• Version Model Number: ECC6560
• Catalog Number: ECC6560
• 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: 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: 6.5 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 60 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M711ECC65600 [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

[M711ECC65600]

Moist Heat or Steam Sterilization

[M711ECC65600]

Moist Heat or Steam Sterilization

[M711ECC65600]

Moist Heat or Steam Sterilization

[M711ECC65600]

Moist Heat or Steam Sterilization

[M711ECC65600]

Moist Heat or Steam Sterilization

[M711ECC65600]

Moist Heat or Steam Sterilization

[M711ECC65600]

Moist Heat or Steam Sterilization

[M711ECC65600]

Moist Heat or Steam Sterilization

[M711ECC65600]

Moist Heat or Steam Sterilization

[M711ECC65600]

Moist Heat or Steam Sterilization

[M711ECC65600]

Moist Heat or Steam Sterilization

[M711ECC65600]

Moist Heat or Steam Sterilization

[M711ECC65600]

Moist Heat or Steam Sterilization

[M711ECC65600]

Moist Heat or Steam Sterilization

[M711ECC65600]

Moist Heat or Steam Sterilization

[M711ECC65600]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2024-05-21
• Device Publish Date: 2019-07-05

On-Brand Devices [Excella 3® ]

• M711E385600: Ti 6Al 4V (ELI)
• M711E385550: Ti 6Al 4V (ELI)
• M711E385500: Ti 6Al 4V (ELI)
• M711E385450: Ti 6Al 4V (ELI)
• M711E385400: Ti 6Al 4V (ELI)
• M711E385350: Ti 6Al 4V (ELI)
• M711E385300: Ti 6Al 4V (ELI)
• M711E375600: Ti 6Al 4V (ELI)
• M711E375550: Ti 6Al 4V (ELI)
• M711E375500: Ti 6Al 4V (ELI)
• M711E375450: Ti 6Al 4V (ELI)
• M711E375400: Ti 6Al 4V (ELI)
• M711E375350: Ti 6Al 4V (ELI)
• M711E375300: Ti 6Al 4V (ELI)
• M711E365600: Ti 6Al 4V (ELI)
• M711E365550: Ti 6Al 4V (ELI)
• M711E365500: Ti 6Al 4V (ELI)
• M711E365450: Ti 6Al 4V (ELI)
• M711E365400: Ti 6Al 4V (ELI)
• M711E365350: Ti 6Al 4V (ELI)
• M711E365300: Ti 6Al 4V (ELI)
• M711E365250: Ti 6Al 4V (ELI)
• M711E355550: Ti 6Al 4V (ELI)
• M711E355500: Ti 6Al 4V (ELI)
• M711E355450: Ti 6Al 4V (ELI)
• M711E355400: Ti 6Al 4V (ELI)
• M711E355350: Ti 6Al 4V (ELI)
• M711E355300: Ti 6Al 4V (ELI)
• M711E355250: Ti 6Al 4V (ELI)
• M711E3475450: Ti 6Al 4V (ELI)
• M711E3475400: Ti 6Al 4V (ELI)
• M711E3475350: Ti 6Al 4V (ELI)
• M711E3475300: Ti 6Al 4V (ELI)
• M711E3475250: Ti 6Al 4V (ELI)
• M711ECC75600: Ti 6Al 4V (ELI)
• M711ECC75550: Ti 6Al 4V (ELI)
• M711ECC75500: Ti 6Al 4V (ELI)
• M711ECC75450: Ti 6Al 4V (ELI)
• M711ECC75400: Ti 6Al 4V (ELI)
• M711ECC75350: Ti 6Al 4V (ELI)
• M711ECC75300: Ti 6Al 4V (ELI)
• M711ECC65600: Ti 6Al 4V (ELI)
• M711ECC65550: Ti 6Al 4V (ELI)
• M711ECC65500: Ti 6Al 4V (ELI)
• M711ECC65450: Ti 6Al 4V (ELI)
• M711ECC65400: Ti 6Al 4V (ELI)
• M711ECC65350: Ti 6Al 4V (ELI)
• M711ECC65300: Ti 6Al 4V (ELI)
• M711ECC65250: Ti 6Al 4V (ELI)
• M711ECC55550: Ti 6Al 4V (ELI)