Integra® Freedom Wrist Arthroplasty System 348002

GUDID M2683480021

The Integra Freedom Wrist Arthroplasty carpal plate is used in an assembly with the carpal implant, and is fixed into the carpal bones with a central peg and two screws and locking caps.

INTEGRA LIFESCIENCES CORPORATION

Total wrist prosthesis

• Primary Device ID: M2683480021
• NIH Device Record Key: 88e38642-ee87-4498-b48b-84e11c6044d0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Integra® Freedom Wrist Arthroplasty System
• Version Model Number: 348002
• Catalog Number: 348002
• 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

Device Dimensions

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Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.

Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780066613 [Primary]
HIBCC	M2683480021 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132250

FDA Product Code

• JWJ: Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained

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® Freedom Wrist Arthroplasty System]

• M2483480551: Integra® Freedom Wrist Arthroplasty System Modular Drill Guide
• M2483481911: Integra® Freedom Wrist Arthroplasty System Radial Drill Guide, Right
• M2483481891: Integra® Freedom Wrist Arthroplasty System Radial Drill Guide, Left
• M2483481451: Integra® Freedom Wrist Arthroplasty System Radial Resection Guide Size 2
• M2483481441: Integra® Freedom Wrist Arthroplasty System Radial Resection Guide Size 1
• M2483481431: Integra® Freedom Wrist Arthroplasty System Radial Feeler
• M2483481371: Integra® Freedom Wrist Arthroplasty System Radial Trial, Size 3 Right
• M2483480751: Integra® Freedom Wrist Arthroplasty System Carpal Reamer, Size 3
• M2483480721: Integra® Freedom Wrist Arthroplasty System Carpal Reamer, Size 2
• M2483480701: Integra® Freedom Wrist Arthroplasty System Carpal Reamer, Size 1
• M2483480681: Integra® Freedom Wrist Arthroplasty System Hamate Feeler
• M2483480611: Integra® Freedom Wrist Arthroplasty System Carpal Resection Guide
• M2483482811: Integra® Freedom Wrist Arthroplasty System Instrument Case Insert
• M2483482801: Integra® Freedom Wrist Arthroplasty System Instrument Case Base
• M268348345E1: The Integra Freedom Wrist Arthroplasty Screw and Locking Cap are used in the assembly of a carpa
• M268348335E1: The Integra Freedom Wrist Arthroplasty Screw and Locking Cap are used in the assembly of a carpa
• M268348330E1: The Integra Freedom Wrist Arthroplasty Screw and Locking Cap are used in the assembly of a carpa
• M268348325E1: The Integra Freedom Wrist Arthroplasty Screw and Locking Cap are used in the assembly of a carpa
• M268348320E1: The Integra Freedom Wrist Arthroplasty Screw and Locking Cap are used in the assembly of a carpa
• M268348317E1: The Integra Freedom Wrist Arthroplasty Screw and Locking Cap are used in the assembly of a carpa
• M268348315E1: The Integra Freedom Wrist Arthroplasty Screw and Locking Cap are used in the assembly of a carpa
• M2683483451: The Integra Freedom Wrist Arthroplasty Screw and Locking Cap are used in the assembly of a carpa
• M2683483401: The Integra Freedom Wrist Arthroplasty Screw and Locking Cap are used in the assembly of a carpa
• M2683483351: The Integra Freedom Wrist Arthroplasty Screw and Locking Cap are used in the assembly of a carpa
• M2683483301: The Integra Freedom Wrist Arthroplasty Screw and Locking Cap are used in the assembly of a carpa
• M2683483251: The Integra Freedom Wrist Arthroplasty Screw and Locking Cap are used in the assembly of a carpa
• M2683483201: The Integra Freedom Wrist Arthroplasty Screw and Locking Cap are used in the assembly of a carpa
• M2683483171: The Integra Freedom Wrist Arthroplasty Screw and Locking Cap are used in the assembly of a carpa
• M2683483151: The Integra Freedom Wrist Arthroplasty Screw and Locking Cap are used in the assembly of a carpa
• M268348200E1: The Integra Freedom Wrist Arthroplasty screw locking cap is used in an assembly consisting of a
• M268348240E1: The Integra Freedom Wrist Arthroplasty screw is used in the assembly of a carpal plate and carpa
• M268348235E1: The Integra Freedom Wrist Arthroplasty screw is used in the assembly of a carpal plate and carpa
• M268348230E1: The Integra Freedom Wrist Arthroplasty screw is used in the assembly of a carpal plate and carpa
• M268348225E1: The Integra Freedom Wrist Arthroplasty screw is used in the assembly of a carpal plate and carpa
• M268348220E1: The Integra Freedom Wrist Arthroplasty screw is used in the assembly of a carpal plate and carpa
• M268348217E1: The Integra Freedom Wrist Arthroplasty screw is used in the assembly of a carpal plate and carpa
• M268348215E1: The Integra Freedom Wrist Arthroplasty screw is used in the assembly of a carpal plate and carpa
• M2683482001: The Integra Freedom Wrist Arthroplasty screw locking cap is used in an assembly consisting of a
• M2683482451: The Integra Freedom Wrist Arthroplasty screw is used in the assembly of a carpal plate and carpa
• M2683482401: The Integra Freedom Wrist Arthroplasty screw is used in the assembly of a carpal plate and carpa
• M2683482351: The Integra Freedom Wrist Arthroplasty screw is used in the assembly of a carpal plate and carpa
• M2683482301: The Integra Freedom Wrist Arthroplasty screw is used in the assembly of a carpal plate and carpa
• M2683482251: The Integra Freedom Wrist Arthroplasty screw is used in the assembly of a carpal plate and carpa
• M2683482201: The Integra Freedom Wrist Arthroplasty screw is used in the assembly of a carpal plate and carpa
• M2683482171: The Integra Freedom Wrist Arthroplasty screw is used in the assembly of a carpal plate and carpa
• M2683482151: The Integra Freedom Wrist Arthroplasty screw is used in the assembly of a carpal plate and carpa
• M268348299E1: The Integra Freedom Wrist Arthroplasty carpal implant is used in an assembly consisting of a tit
• M268348298E1: The Integra Freedom Wrist Arthroplasty carpal implant is used in an assembly consisting of a tit
• M268348297E1: The Integra Freedom Wrist Arthroplasty carpal implant is used in an assembly consisting of a tit
• M268348296E1: The Integra Freedom Wrist Arthroplasty carpal implant is used in an assembly consisting of a tit