Integra® External Fixation System 12225200

GUDID 10381780125402

The strut is an adjustable component designed to facilitate building and maintaining frames, from initial surgery to follow-up care. This strut features a tightened mode which 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: 10381780125402
• NIH Device Record Key: c04f5182-a56c-4997-80dc-9c07b4c74990
• Commercial Distribution Discontinuation: 2023-03-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Integra® External Fixation System
• Version Model Number: 12225200
• Catalog Number: 12225200
• 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

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 Identifiers

Device Issuing Agency	Device ID
GS1	10381780125402 [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

[10381780125402]

Moist Heat or Steam Sterilization

[10381780125402]

Moist Heat or Steam Sterilization

[10381780125402]

Moist Heat or Steam Sterilization

[10381780125402]

Moist Heat or Steam Sterilization

[10381780125402]

Moist Heat or Steam Sterilization

[10381780125402]

Moist Heat or Steam Sterilization

[10381780125402]

Moist Heat or Steam Sterilization

[10381780125402]

Moist Heat or Steam Sterilization

[10381780125402]

Moist Heat or Steam Sterilization

[10381780125402]

Moist Heat or Steam Sterilization

[10381780125402]

Moist Heat or Steam Sterilization

[10381780125402]

Moist Heat or Steam Sterilization

[10381780125402]

Moist Heat or Steam Sterilization

[10381780125402]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2023-05-03
• 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