Integra® Freedom Wrist Arthroplasty System 348131E

GUDID M268348131E1

The Integra Freedom Wrist Arthroplasty radial component is made of Cobalt Chrome Molybdenum Alloy (CoCrMo) and has a concave articulating surface and is fixed by means of a stem which is inserted into the radial intramedullary canal.

INTEGRA LIFESCIENCES CORPORATION

Total wrist prosthesis

• Primary Device ID: M268348131E1
• NIH Device Record Key: bb68037d-5c88-4375-8d31-3ee45ea670f0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Integra® Freedom Wrist Arthroplasty System
• Version Model Number: 348131E
• Catalog Number: 348131E
• 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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Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780066859 [Primary]
HIBCC	M268348131E1 [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