Integra® Total Wrist Fusion System WRISTFUSESET

GUDID M268WRISTFUSESET0

The Total Wrist Fusion System (WRISTFUSEEST) consists of two pre-contoured plates with eight holes and a straight plate with nine holes. These plates are fixed to the bone with 2.7mm diameter and 3.5mm diameter screws. Instrumentation is provided to assist in the implantation. Screws with a diameter of 2.7mm vary in size length from 10mm to 24mm. Screws with a diameter of 3.5mm vary in size length from 12mm to 28mm. This system is generally indicated for use in patients with arthritis of the joints of the wrist, rheumatoid wrist deformities, carpal instability, wrist pain, brachial plexus nerve palsies, and loss of function due to osteoarthritis.

INTEGRA LIFESCIENCES CORPORATION

Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable

• Primary Device ID: M268WRISTFUSESET0
• NIH Device Record Key: 0ed23ab1-376b-4244-b23b-4e8602d40956
• Commercial Distribution Discontinuation: 2023-12-04
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Integra® Total Wrist Fusion System
• Version Model Number: WRISTFUSESET
• Catalog Number: WRISTFUSESET
• Company DUNS: 963856096
• Company Name: INTEGRA LIFESCIENCES CORPORATION
• 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

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 Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780064350 [Primary]
HIBCC	M268WRISTFUSESET0 [Secondary]

FDA Product Code

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

Sterilization

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

[M268WRISTFUSESET0]

Moist Heat or Steam Sterilization

[M268WRISTFUSESET0]

Moist Heat or Steam Sterilization

[M268WRISTFUSESET0]

Moist Heat or Steam Sterilization

[M268WRISTFUSESET0]

Moist Heat or Steam Sterilization

[M268WRISTFUSESET0]

Moist Heat or Steam Sterilization

[M268WRISTFUSESET0]

Moist Heat or Steam Sterilization

[M268WRISTFUSESET0]

Moist Heat or Steam Sterilization

[M268WRISTFUSESET0]

Moist Heat or Steam Sterilization

[M268WRISTFUSESET0]

Moist Heat or Steam Sterilization

[M268WRISTFUSESET0]

Moist Heat or Steam Sterilization

[M268WRISTFUSESET0]

Moist Heat or Steam Sterilization

[M268WRISTFUSESET0]

Moist Heat or Steam Sterilization

[M268WRISTFUSESET0]

Moist Heat or Steam Sterilization

[M268WRISTFUSESET0]

Moist Heat or Steam Sterilization

[M268WRISTFUSESET0]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2024-04-05
• Device Publish Date: 2015-08-15

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

• M2483035111: INSTRUMENT CASE BASE (EMEA)
• M2483035101: INSTRUMENT CASE COMPLETE - EMEA
• M2483035051: INSTRUMENT CASE IMPLANT CADDY LID (US)
• M2483035041: INSTRUMENT CASE LID (US/EMEA)
• M2483035031: INSTRUMENT CASE IMPLANT CADDY (US)
• M2483035021: INSTRUMENT CASE TOP LEVEL (US/EMEA)
• M2483035011: INSTRUMENT CASE BASE (US)
• M2483035001: INSTRUMENT CASE COMPLETE - US
• M248303328CS1: Total Wrist Fusion cortical screw
• M248303326CS1: Total Wrist Fusion cortical screw
• M248303324CS1: Total Wrist Fusion cortical screw
• M248303322CS1: Total Wrist Fusion cortical screw
• M248303320CS1: Total Wrist Fusion cortical screw
• M248303318CS1: Total Wrist Fusion cortical screw
• M248303316CS1: Total Wrist Fusion cortical screw
• M248303314CS1: Total Wrist Fusion cortical screw
• M248303312CS1: Total Wrist Fusion cortical screw
• M248303224CS1: Total Wrist Fusion cortical screw
• M248303222CS1: Total Wrist Fusion cortical screw
• M248303220CS1: Total Wrist Fusion cortical screw
• M248303218CS1: Total Wrist Fusion cortical screw
• M248303216CS1: Total Wrist Fusion cortical screw
• M248303214CS1: Total Wrist Fusion cortical screw
• M248303212CS1: Total Wrist Fusion cortical screw
• M248303210CS1: Total Wrist Fusion cortical screw
• M248303102S1: The Integra Total Wrist Fusion pre-contoured plates with eight holes are fixed to the bone with
• M248303101S1: The Integra Total Wrist Fusion pre-contoured plates with eight holes are fixed to the bone with
• M248303100S1: The Integra Total Wrist Fusion straight plate with nine holes is fixed to the bone with screws.
• M2483033261: Total Wrist Fusion cortical screw
• M2483033241: Total Wrist Fusion cortical screw
• M2483033221: Total Wrist Fusion cortical screw
• M2483033181: Total Wrist Fusion cortical screw
• M2483033141: Total Wrist Fusion cortical screw
• M2483032241: Total Wrist Fusion cortical screw
• M2483032221: Total Wrist Fusion cortical screw
• M2483032201: Total Wrist Fusion cortical screw
• M2483032181: Total Wrist Fusion cortical screw
• M2483032161: Total Wrist Fusion cortical screw
• M2483032141: Total Wrist Fusion cortical screw
• M2483031021: The Integra Total Wrist Fusion pre-contoured plates with eight holes are fixed to the bone with
• M2483033201: Total Wrist Fusion cortical screw
• M268WRISTFUSESET0: The Total Wrist Fusion System (WRISTFUSEEST) consists of two pre-contoured plates with eight hol