Integra® External Fixation System XFIX4RCKRIMP

GUDID M268XFIX4RCKRIMP1

The Integra External Fixation System set consists of rings, footplates, anterior cross bars, and a rockerbottom. These devices are used for stability and structure. The external fixation device is intended for use in the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amenable to treatment by use of the external fixation modality.

Ascension Orthopedics, Inc.

External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable

• Primary Device ID: M268XFIX4RCKRIMP1
• NIH Device Record Key: 3adc819f-8a15-402d-897f-108f70885537
• Commercial Distribution Discontinuation: 2023-03-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Integra® External Fixation System
• Version Model Number: XFIX4RCKRIMP
• Catalog Number: XFIX4RCKRIMP
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780125723 [Primary]
HIBCC	M268XFIX4RCKRIMP1 [Secondary]

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

[M268XFIX4RCKRIMP1]

Moist Heat or Steam Sterilization

[M268XFIX4RCKRIMP1]

Moist Heat or Steam Sterilization

[M268XFIX4RCKRIMP1]

Moist Heat or Steam Sterilization

[M268XFIX4RCKRIMP1]

Moist Heat or Steam Sterilization

[M268XFIX4RCKRIMP1]

Moist Heat or Steam Sterilization

[M268XFIX4RCKRIMP1]

Moist Heat or Steam Sterilization

[M268XFIX4RCKRIMP1]

Moist Heat or Steam Sterilization

[M268XFIX4RCKRIMP1]

Moist Heat or Steam Sterilization

[M268XFIX4RCKRIMP1]

Moist Heat or Steam Sterilization

[M268XFIX4RCKRIMP1]

Moist Heat or Steam Sterilization

[M268XFIX4RCKRIMP1]

Moist Heat or Steam Sterilization

[M268XFIX4RCKRIMP1]

Moist Heat or Steam Sterilization

[M268XFIX4RCKRIMP1]

Moist Heat or Steam Sterilization

[M268XFIX4RCKRIMP1]

Moist Heat or Steam Sterilization

[M268XFIX4RCKRIMP1]

Moist Heat or Steam Sterilization

[M268XFIX4RCKRIMP1]

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: 2015-09-22

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