Integra® Ti6® TC4014

GUDID 10381780115144

Ti6 Low Profile Bone Screw

Ascension Orthopedics, Inc.

Orthopaedic bone screw, non-bioabsorbable, non-sterile

• Primary Device ID: 10381780115144
• NIH Device Record Key: ea911edd-8ea5-48fa-a0d3-c2d3a04c2fa9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Integra® Ti6®
• Version Model Number: TC4014
• Catalog Number: TC4014
• Company DUNS: 942377524
• Company Name: Ascension Orthopedics, 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: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780115144 [Primary]
HIBCC	M268TC40141 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060026

FDA Product Code

• HWC: Screw, fixation, bone

Sterilization

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

[10381780115144]

Moist Heat or Steam Sterilization

[10381780115144]

Moist Heat or Steam Sterilization

[10381780115144]

Moist Heat or Steam Sterilization

[10381780115144]

Moist Heat or Steam Sterilization

[10381780115144]

Moist Heat or Steam Sterilization

[10381780115144]

Moist Heat or Steam Sterilization

[10381780115144]

Moist Heat or Steam Sterilization

[10381780115144]

Moist Heat or Steam Sterilization

[10381780115144]

Moist Heat or Steam Sterilization

[10381780115144]

Moist Heat or Steam Sterilization

[10381780115144]

Moist Heat or Steam Sterilization

[10381780115144]

Moist Heat or Steam Sterilization

[10381780115144]

Moist Heat or Steam Sterilization

[10381780115144]

Moist Heat or Steam Sterilization

[10381780115144]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-12-24
• Device Publish Date: 2017-10-09

On-Brand Devices [Integra® Ti6®]

• M269FS10051: The titanium swivel driver handle is useful for inserting small screws.
• 10381780115144: Ti6 Low Profile Bone Screw