Integra® Total Foot System" RFOOTIMP

GUDID M268RFOOTIMP1

The Integra Total Foot System is a system containing bone plates and screws designed for use in the skeletally mature foot. The plates and screws are intended to be used for stabilization and fixation of fresh fractures, intra-articular and extra-articular fractures, joint depression and multi-fragmentary fractures. The subject devices can also be used in revision procedures, joint fusion, and in reconstructing the small bones of the feet. Implants are manufactured from Titanium Alloy. The rear foot plates include lapidus plates, interpositioning plates, universal rear foot plates, rear foot reconstruction plates, flat line arthrodesis plates, dwyer displacement plates, calcaneus plates, and fibular plates. Also included are 3.7mm locking screws.

Ascension Orthopedics, Inc.

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile

• Primary Device ID: M268RFOOTIMP1
• NIH Device Record Key: e736e17f-b86d-47bf-8e27-9a040da265e1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Integra® Total Foot System"
• Version Model Number: RFOOTIMP
• Catalog Number: RFOOTIMP
• 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	10381780064640 [Primary]
HIBCC	M268RFOOTIMP1 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100502

FDA Product Code

• HWC: Screw, fixation, bone

Sterilization

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

[M268RFOOTIMP1]

Moist Heat or Steam Sterilization

[M268RFOOTIMP1]

Moist Heat or Steam Sterilization

[M268RFOOTIMP1]

Moist Heat or Steam Sterilization

[M268RFOOTIMP1]

Moist Heat or Steam Sterilization

[M268RFOOTIMP1]

Moist Heat or Steam Sterilization

[M268RFOOTIMP1]

Moist Heat or Steam Sterilization

[M268RFOOTIMP1]

Moist Heat or Steam Sterilization

[M268RFOOTIMP1]

Moist Heat or Steam Sterilization

[M268RFOOTIMP1]

Moist Heat or Steam Sterilization

[M268RFOOTIMP1]

Moist Heat or Steam Sterilization

[M268RFOOTIMP1]

Moist Heat or Steam Sterilization

[M268RFOOTIMP1]

Moist Heat or Steam Sterilization

[M268RFOOTIMP1]

Moist Heat or Steam Sterilization

[M268RFOOTIMP1]

Moist Heat or Steam Sterilization

[M268RFOOTIMP1]

Moist Heat or Steam Sterilization

[M268RFOOTIMP1]

Moist Heat or Steam Sterilization

[M268RFOOTIMP1]

Moist Heat or Steam Sterilization

[M268RFOOTIMP1]

Moist Heat or Steam Sterilization

[M268RFOOTIMP1]

Moist Heat or Steam Sterilization

[M268RFOOTIMP1]

Moist Heat or Steam Sterilization

[M268RFOOTIMP1]

Moist Heat or Steam Sterilization

[M268RFOOTIMP1]

Moist Heat or Steam Sterilization

[M268RFOOTIMP1]

Moist Heat or Steam Sterilization

[M268RFOOTIMP1]

Moist Heat or Steam Sterilization

[M268RFOOTIMP1]

Moist Heat or Steam Sterilization

[M268RFOOTIMP1]

Moist Heat or Steam Sterilization

[M268RFOOTIMP1]

Moist Heat or Steam Sterilization

[M268RFOOTIMP1]

Moist Heat or Steam Sterilization

[M268RFOOTIMP1]

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® Total Foot System"]

• M268RFOOTIMP1: The Integra Total Foot System is a system containing bone plates and screws designed for use in
• M268FFMFOOTIMP1: The Integra Total Foot System is a system containing bone plates and screws designed for use in
• M268TFSREARFTIMP1: The Integra Total Foot System is a system containing bone plates and screws designed for use in
• M268TFSFOREFTIMP1: The Integra Total Foot System is a system containing bone plates and screws designed for use in
• M268TARSALISIMP1: The Integra Total Foot System is a system containing bone plates and screws designed for use in