Integra® Total Wrist Fusion System 303218CS

GUDID M248303218CS1

Total Wrist Fusion cortical screw

INTEGRA LIFESCIENCES CORPORATION

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

• Primary Device ID: M248303218CS1
• NIH Device Record Key: 6d11f2a9-3468-4363-a42f-c250aefca0df
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Integra® Total Wrist Fusion System
• Version Model Number: 303218CS
• Catalog Number: 303218CS
• 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: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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
• 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	10381780066330 [Primary]
HIBCC	M248303218CS1 [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: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-02-26
• Device Publish Date: 2017-10-09

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