Integra® Total Wrist Fusion System 303100

GUDID M2483031001

The Integra Total Wrist Fusion straight plate with nine holes is fixed to the bone with screws.

Ascension Orthopedics, Inc.

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

• Primary Device ID: M2483031001
• NIH Device Record Key: 3d15658d-0c5a-4563-9067-52dd49a9708d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Integra® Total Wrist Fusion System
• Version Model Number: 303100
• Catalog Number: 303100
• 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	10381780065197 [Primary]
HIBCC	M2483031001 [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

[M2483031001]

Moist Heat or Steam Sterilization

[M2483031001]

Moist Heat or Steam Sterilization

[M2483031001]

Moist Heat or Steam Sterilization

[M2483031001]

Moist Heat or Steam Sterilization

[M2483031001]

Moist Heat or Steam Sterilization

[M2483031001]

Moist Heat or Steam Sterilization

[M2483031001]

Moist Heat or Steam Sterilization

[M2483031001]

Moist Heat or Steam Sterilization

[M2483031001]

Moist Heat or Steam Sterilization

[M2483031001]

Moist Heat or Steam Sterilization

[M2483031001]

Moist Heat or Steam Sterilization

[M2483031001]

Moist Heat or Steam Sterilization

[M2483031001]

Moist Heat or Steam Sterilization

[M2483031001]

Moist Heat or Steam Sterilization

[M2483031001]

Moist Heat or Steam Sterilization

[M2483031001]

Moist Heat or Steam Sterilization

[M2483031001]

Moist Heat or Steam Sterilization

[M2483031001]

Moist Heat or Steam Sterilization

[M2483031001]

Moist Heat or Steam Sterilization

[M2483031001]

Moist Heat or Steam Sterilization

[M2483031001]

Moist Heat or Steam Sterilization

[M2483031001]

Moist Heat or Steam Sterilization

[M2483031001]

Moist Heat or Steam Sterilization

[M2483031001]

Moist Heat or Steam Sterilization

[M2483031001]

Moist Heat or Steam Sterilization

[M2483031001]

Moist Heat or Steam Sterilization

[M2483031001]

Moist Heat or Steam Sterilization

[M2483031001]

Moist Heat or Steam Sterilization

[M2483031001]

Moist Heat or Steam Sterilization

[M2483031001]

Moist Heat or Steam Sterilization

[M2483031001]

Moist Heat or Steam Sterilization

[M2483031001]

Moist Heat or Steam Sterilization

[M2483031001]

Moist Heat or Steam Sterilization

[M2483031001]

Moist Heat or Steam Sterilization

[M2483031001]

Moist Heat or Steam Sterilization

[M2483031001]

Moist Heat or Steam Sterilization

[M2483031001]

Moist Heat or Steam Sterilization

[M2483031001]

Moist Heat or Steam Sterilization

[M2483031001]

Moist Heat or Steam Sterilization

[M2483031001]

Moist Heat or Steam Sterilization

[M2483031001]

Moist Heat or Steam Sterilization

[M2483031001]

Moist Heat or Steam Sterilization

[M2483031001]

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.