Integra® External Fixation System 12225210

GUDID 10381780125419

The strut is an adjustable component designed to facilitate building and maintaining frames, from initial surgery to follow-up care. This strut features an unlocked mode, where large adjustments may be made to the component’s vertical translation. It also features one distal end which is designed to enable construction of frames with offset rings or different diameter rings. The tightened mode allows for fine adjustments in vertical translation; this enables surgeons to conveniently apply compression and distraction to the frame, both intra-operatively and post-operatively. The fully locked mode restricts translation and angular movement creating a rigid construct.

Ascension Orthopedics, Inc.

External orthopaedic fixation system, reusable

• Primary Device ID: 10381780125419
• NIH Device Record Key: 1cc8c922-2964-4cc0-a481-6c327a1ae278
• Commercial Distribution Discontinuation: 2023-03-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Integra® External Fixation System
• Version Model Number: 12225210
• Catalog Number: 12225210
• 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
• 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 Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780125419 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140463

FDA Product Code

• KTT: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Sterilization

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

[10381780125419]

Moist Heat or Steam Sterilization

[10381780125419]

Moist Heat or Steam Sterilization

[10381780125419]

Moist Heat or Steam Sterilization

[10381780125419]

Moist Heat or Steam Sterilization

[10381780125419]

Moist Heat or Steam Sterilization

[10381780125419]

Moist Heat or Steam Sterilization

[10381780125419]

Moist Heat or Steam Sterilization

[10381780125419]

Moist Heat or Steam Sterilization

[10381780125419]

Moist Heat or Steam Sterilization

[10381780125419]

Moist Heat or Steam Sterilization

[10381780125419]

Moist Heat or Steam Sterilization

[10381780125419]

Moist Heat or Steam Sterilization

[10381780125419]

Moist Heat or Steam Sterilization

[10381780125419]

Moist Heat or Steam Sterilization

[10381780125419]

Moist Heat or Steam Sterilization

[10381780125419]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2023-05-02
• Device Publish Date: 2017-10-09

On-Brand Devices [Integra® External Fixation System]

• M268XFIX4RCKRIMP1: The Integra External Fixation System set consists of rings, footplates, anterior cross bars, and
• 10381780125679: The Integra External Fixation System two-post bridge is manufactured from stainless steel. It is
• 10381780125426: The strut is an adjustable component designed to facilitate building and maintaining frames, fro
• 10381780125419: The strut is an adjustable component designed to facilitate building and maintaining frames, fro
• M268XFIX5RINGIMP1: The Integra External Fixation System set consists of rings and footplates. These devices are use
• M268XFIX2RODSIMP1: The Integra External Fixation System set consists of struts, rods, and hex posts. These devices
• M268XFIX1BOLTIMP1: The Integra External Fixation System set consists of wires, half-pins, nuts, and bolts. Instrume
• 10381780125402: The strut is an adjustable component designed to facilitate building and maintaining frames, fro