Integra® Ti6® Internal Fixation System TI6LOPROIMP

GUDID M268TI6LOPROIMP1

The Integra Ti6 Internal Fixation System is comprised of Low Profile screws used for bone fixation of the hand and foot following trauma or osteotomy. The low profile screw is a cannulated, threaded bone screw which is offered in 2.0, 2.5, 3.0 and 4.0 diameters with lengths of 2.0, 2.5, 3.0, and 4.0. The system includes titanium and stainless steel instruments to facilitate the placement of the screws.

Ascension Orthopedics, Inc.

Orthopaedic bone screw, non-bioabsorbable, non-sterile

• Primary Device ID: M268TI6LOPROIMP1
• NIH Device Record Key: 9152a170-2329-42b2-8c3f-1cda732d74df
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Integra® Ti6® Internal Fixation System
• Version Model Number: TI6LOPROIMP
• Catalog Number: TI6LOPROIMP
• 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: true
• 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: +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
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	10381780074328 [Primary]
HIBCC	M268TI6LOPROIMP1 [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

[M268TI6LOPROIMP1]

Moist Heat or Steam Sterilization

[M268TI6LOPROIMP1]

Moist Heat or Steam Sterilization

[M268TI6LOPROIMP1]

Moist Heat or Steam Sterilization

[M268TI6LOPROIMP1]

Moist Heat or Steam Sterilization

[M268TI6LOPROIMP1]

Moist Heat or Steam Sterilization

[M268TI6LOPROIMP1]

Moist Heat or Steam Sterilization

[M268TI6LOPROIMP1]

Moist Heat or Steam Sterilization

[M268TI6LOPROIMP1]

Moist Heat or Steam Sterilization

[M268TI6LOPROIMP1]

Moist Heat or Steam Sterilization

[M268TI6LOPROIMP1]

Moist Heat or Steam Sterilization

[M268TI6LOPROIMP1]

Moist Heat or Steam Sterilization

[M268TI6LOPROIMP1]

Moist Heat or Steam Sterilization

[M268TI6LOPROIMP1]

Moist Heat or Steam Sterilization

[M268TI6LOPROIMP1]

Moist Heat or Steam Sterilization

[M268TI6LOPROIMP1]

Moist Heat or Steam Sterilization

[M268TI6LOPROIMP1]

Moist Heat or Steam Sterilization

[M268TI6LOPROIMP1]

Moist Heat or Steam Sterilization

[M268TI6LOPROIMP1]

Moist Heat or Steam Sterilization

[M268TI6LOPROIMP1]

Moist Heat or Steam Sterilization

[M268TI6LOPROIMP1]

Moist Heat or Steam Sterilization

[M268TI6LOPROIMP1]

Moist Heat or Steam Sterilization

[M268TI6LOPROIMP1]

Moist Heat or Steam Sterilization

[M268TI6LOPROIMP1]

Moist Heat or Steam Sterilization

[M268TI6LOPROIMP1]

Moist Heat or Steam Sterilization

[M268TI6LOPROIMP1]

Moist Heat or Steam Sterilization

[M268TI6LOPROIMP1]

Moist Heat or Steam Sterilization

[M268TI6LOPROIMP1]

Moist Heat or Steam Sterilization

[M268TI6LOPROIMP1]

Moist Heat or Steam Sterilization

[M268TI6LOPROIMP1]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-07-16
• Device Publish Date: 2015-09-22

On-Brand Devices [Integra® Ti6® Internal Fixation System]

• M268TI6SOLIDIMP1: The Integra Ti6 Internal Fixation System is comprised of Solid Bone screws used for bone fixat
• M268TI6LOPROIMP1: The Integra Ti6 Internal Fixation System is comprised of Low Profile screws used for bone fixati
• M268TI6HLESSIMP1: The Integra Ti6 Internal Fixation System is comprised of Headless screws used for bone fixation
• M268TI6DIGITIMP1: The Integra Ti6 Internal Fixation System is comprised of Digital screws used for bone fixation o