Integra® Total Wrist Fusion System 303101

GUDID M2483031011

The Integra Total Wrist Fusion pre-contoured plates with eight holes are fixed to the bone with screws.

Ascension Orthopedics, Inc.

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

• Primary Device ID: M2483031011
• NIH Device Record Key: 7515a55e-0ae8-49e4-b790-838334d82a12
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Integra® Total Wrist Fusion System
• Version Model Number: 303101
• Catalog Number: 303101
• 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: 800-654-2873
• Email: custsvnj@integralife.com
• Phone: 800-654-2873
• Email: custsvnj@integralife.com
• Phone: 800-654-2873
• Email: custsvnj@integralife.com
• Phone: 800-654-2873
• Email: custsvnj@integralife.com
• Phone: 800-654-2873
• Email: custsvnj@integralife.com
• Phone: 800-654-2873
• Email: custsvnj@integralife.com
• Phone: 800-654-2873
• Email: custsvnj@integralife.com
• Phone: 800-654-2873
• Email: custsvnj@integralife.com
• Phone: 800-654-2873
• Email: custsvnj@integralife.com
• Phone: 800-654-2873
• Email: custsvnj@integralife.com
• Phone: 800-654-2873
• Email: custsvnj@integralife.com
• Phone: 800-654-2873
• Email: custsvnj@integralife.com
• Phone: 800-654-2873
• Email: custsvnj@integralife.com
• Phone: 800-654-2873
• Email: custsvnj@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
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com

Device Dimensions

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Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780065203 [Primary]
HIBCC	M2483031011 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093163

FDA Product Code

• LXT: Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite

Sterilization

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

[M2483031011]

Moist Heat or Steam Sterilization

[M2483031011]

Moist Heat or Steam Sterilization

[M2483031011]

Moist Heat or Steam Sterilization

[M2483031011]

Moist Heat or Steam Sterilization

[M2483031011]

Moist Heat or Steam Sterilization

[M2483031011]

Moist Heat or Steam Sterilization

[M2483031011]

Moist Heat or Steam Sterilization

[M2483031011]

Moist Heat or Steam Sterilization

[M2483031011]

Moist Heat or Steam Sterilization

[M2483031011]

Moist Heat or Steam Sterilization

[M2483031011]

Moist Heat or Steam Sterilization

[M2483031011]

Moist Heat or Steam Sterilization

[M2483031011]

Moist Heat or Steam Sterilization

[M2483031011]

Moist Heat or Steam Sterilization

[M2483031011]

Moist Heat or Steam Sterilization

[M2483031011]

Moist Heat or Steam Sterilization

[M2483031011]

Moist Heat or Steam Sterilization

[M2483031011]

Moist Heat or Steam Sterilization

[M2483031011]

Moist Heat or Steam Sterilization

[M2483031011]

Moist Heat or Steam Sterilization

[M2483031011]

Moist Heat or Steam Sterilization

[M2483031011]

Moist Heat or Steam Sterilization

[M2483031011]

Moist Heat or Steam Sterilization

[M2483031011]

Moist Heat or Steam Sterilization

[M2483031011]

Moist Heat or Steam Sterilization

[M2483031011]

Moist Heat or Steam Sterilization

[M2483031011]

Moist Heat or Steam Sterilization

[M2483031011]

Moist Heat or Steam Sterilization

[M2483031011]

Moist Heat or Steam Sterilization

[M2483031011]

Moist Heat or Steam Sterilization

[M2483031011]

Moist Heat or Steam Sterilization

[M2483031011]

Moist Heat or Steam Sterilization

[M2483031011]

Moist Heat or Steam Sterilization

[M2483031011]

Moist Heat or Steam Sterilization

[M2483031011]

Moist Heat or Steam Sterilization

[M2483031011]

Moist Heat or Steam Sterilization

[M2483031011]

Moist Heat or Steam Sterilization

[M2483031011]

Moist Heat or Steam Sterilization

[M2483031011]

Moist Heat or Steam Sterilization

[M2483031011]

Moist Heat or Steam Sterilization

[M2483031011]

Moist Heat or Steam Sterilization

[M2483031011]

Moist Heat or Steam Sterilization

[M2483031011]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-03-04
• Device Publish Date: 2017-10-09

On-Brand Devices [Integra® Total Wrist Fusion System]

• M2483034021: 2.7 MM DRILL BIT
• M2483034011: 2.5 MM DRILL BIT
• M2483034001: 2.0 MM DRILL BIT
• M2483034521: SHORT BEND PLATE TRIAL
• M2483034511: STANDARD BEND PLATE TRIAL
• M2483034501: STRAIGHT PLATE TRIAL
• M2483034071: DEPTH GAUGE
• M2483034121: PLATE BENDER 3.5 MM HOLE
• M2483034111: PLATE BENDER 2.7 MM HOLE
• M2483034101: 2.0 MM, SELF RETAINING HEX DRIVER
• M2483034091: 2.5 MM, SELF RETAINING HEX DRIVER
• M2483034081: SELF RETAINING STAR DRIVER
• M2483034061: 3.5MM THREADED DRILL GUIDE 2.7 MM DRILL BIT
• M2483034051: 2.7MM THREADED DRILL GUIDE 2.0 MM DRILL BIT
• M2483034041: CORTICAL DOUBLE ENDED DRILL GUIDE 2.5 MM DRILL BIT
• M2483034031: CORTICAL DOUBLE ENDED DRILL GUIDE 2.0 MM DRILL BIT
• M2483033281: Total Wrist Fusion cortical screw
• M2483033161: Total Wrist Fusion cortical screw
• M2483033121: Total Wrist Fusion cortical screw
• M2483032121: Total Wrist Fusion cortical screw
• M2483032101: Total Wrist Fusion cortical screw
• M2483031011: The Integra Total Wrist Fusion pre-contoured plates with eight holes are fixed to the bone with
• M2483031001: The Integra Total Wrist Fusion straight plate with nine holes is fixed to the bone with screws.