K2™ Hemi Toe Implant System 2031004

GUDID M24820310041

K2™ Hemi Toe Implant System TOE PLATE

INTEGRA LIFESCIENCES CORPORATION

Partial metatarsophalangeal joint prosthesis

• Primary Device ID: M24820310041
• NIH Device Record Key: 6f5ca793-9eac-4367-a19b-b168bdc028ac
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: K2™ Hemi Toe Implant System
• Version Model Number: 2031004
• Catalog Number: 2031004
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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
• 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

• Device Size Text, specify: 0
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• Device Size Text, specify: 0
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• Device Size Text, specify: 0
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• 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	10381780279471 [Primary]
HIBCC	M24820310041 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K023770

FDA Product Code

• KWD: PROSTHESIS, TOE, HEMI-, PHALANGEAL

Sterilization

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

[M24820310041]

Moist Heat or Steam Sterilization

[M24820310041]

Moist Heat or Steam Sterilization

[M24820310041]

Moist Heat or Steam Sterilization

[M24820310041]

Moist Heat or Steam Sterilization

[M24820310041]

Moist Heat or Steam Sterilization

[M24820310041]

Moist Heat or Steam Sterilization

[M24820310041]

Moist Heat or Steam Sterilization

[M24820310041]

Moist Heat or Steam Sterilization

[M24820310041]

Moist Heat or Steam Sterilization

[M24820310041]

Moist Heat or Steam Sterilization

[M24820310041]

Moist Heat or Steam Sterilization

[M24820310041]

Moist Heat or Steam Sterilization

[M24820310041]

Moist Heat or Steam Sterilization

[M24820310041]

Moist Heat or Steam Sterilization

[M24820310041]

Moist Heat or Steam Sterilization

[M24820310041]

Moist Heat or Steam Sterilization

[M24820310041]

Moist Heat or Steam Sterilization

[M24820310041]

Moist Heat or Steam Sterilization

[M24820310041]

Moist Heat or Steam Sterilization

[M24820310041]

Moist Heat or Steam Sterilization

[M24820310041]

Moist Heat or Steam Sterilization

[M24820310041]

Moist Heat or Steam Sterilization

[M24820310041]

Moist Heat or Steam Sterilization

[M24820310041]

Moist Heat or Steam Sterilization

[M24820310041]

Moist Heat or Steam Sterilization

[M24820310041]

Moist Heat or Steam Sterilization

[M24820310041]

Moist Heat or Steam Sterilization

[M24820310041]

Moist Heat or Steam Sterilization

[M24820310041]

Moist Heat or Steam Sterilization

[M24820310041]

Moist Heat or Steam Sterilization

[M24820310041]

Moist Heat or Steam Sterilization

[M24820310041]

Moist Heat or Steam Sterilization

[M24820310041]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2022-02-21
• Device Publish Date: 2018-04-10

On-Brand Devices [K2™ Hemi Toe Implant System]

• M2482032001: K2 HEMI REAMER
• M2482050021: K2 HEMI BASE
• M2482050011: K2 HEMI LID
• M2482050001: K2 HEMI TRAY
• M248201040KMI1: The K2 Hemi Toe implant is intended for cement fixation by means of a stem, which is inserted in
• M2482010301: The K2 Hemi Toe implant is intended for cement fixation by means of a stem, which is inserted in
• M2482010201: The K2 Hemi Toe implant is intended for cement fixation by means of a stem, which is inserted in
• M2482010101: The K2 Hemi Toe implant is intended for cement fixation by means of a stem, which is inserted in
• M24820310041: K2™ Hemi Toe Implant System TOE PLATE
• M2482030201: K2 HEMI SHAPER SIZE 2
• M24820310051: K2 HEMI GUIDE SCREW