K2™ Hemi Toe Implant System 205001

GUDID M2482050011

K2 HEMI LID

INTEGRA LIFESCIENCES CORPORATION

Instrument tray Instrument tray Instrument tray Instrument tray Instrument tray Instrument tray Instrument tray Instrument tray Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable

• Primary Device ID: M2482050011
• NIH Device Record Key: a203c3fd-53a7-4f00-83a5-a8ebf1260fb3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: K2™ Hemi Toe Implant System
• Version Model Number: 205001
• Catalog Number: 205001
• Company DUNS: 963856096
• Company Name: INTEGRA LIFESCIENCES CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	10381780279518 [Primary]
HIBCC	M2482050011 [Secondary]

FDA Product Code

• FSM: TRAY, SURGICAL, INSTRUMENT

Sterilization

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

[M2482050011]

Moist Heat or Steam Sterilization

[M2482050011]

Moist Heat or Steam Sterilization

[M2482050011]

Moist Heat or Steam Sterilization

[M2482050011]

Moist Heat or Steam Sterilization

[M2482050011]

Moist Heat or Steam Sterilization

[M2482050011]

Moist Heat or Steam Sterilization

[M2482050011]

Moist Heat or Steam Sterilization

[M2482050011]

Moist Heat or Steam Sterilization

[M2482050011]

Moist Heat or Steam Sterilization

[M2482050011]

Moist Heat or Steam Sterilization

[M2482050011]

Moist Heat or Steam Sterilization

[M2482050011]

Moist Heat or Steam Sterilization

[M2482050011]

Moist Heat or Steam Sterilization

[M2482050011]

Moist Heat or Steam Sterilization

[M2482050011]

Moist Heat or Steam Sterilization

[M2482050011]

Moist Heat or Steam Sterilization

[M2482050011]

Moist Heat or Steam Sterilization

[M2482050011]

Moist Heat or Steam Sterilization

[M2482050011]

Moist Heat or Steam Sterilization

[M2482050011]

Moist Heat or Steam Sterilization

[M2482050011]

Moist Heat or Steam Sterilization

[M2482050011]

Moist Heat or Steam Sterilization

[M2482050011]

Moist Heat or Steam Sterilization

[M2482050011]

Moist Heat or Steam Sterilization

[M2482050011]

Moist Heat or Steam Sterilization

[M2482050011]

Moist Heat or Steam Sterilization

[M2482050011]

Moist Heat or Steam Sterilization

[M2482050011]

Moist Heat or Steam Sterilization

[M2482050011]

Moist Heat or Steam Sterilization

[M2482050011]

Moist Heat or Steam Sterilization

[M2482050011]

Moist Heat or Steam Sterilization

[M2482050011]

Moist Heat or Steam Sterilization

[M2482050011]

Moist Heat or Steam Sterilization

[M2482050011]

Moist Heat or Steam Sterilization

[M2482050011]

Moist Heat or Steam Sterilization

[M2482050011]

Moist Heat or Steam Sterilization

[M2482050011]

Moist Heat or Steam Sterilization

[M2482050011]

Moist Heat or Steam Sterilization

[M2482050011]

Moist Heat or Steam Sterilization

[M2482050011]

Moist Heat or Steam Sterilization

[M2482050011]

Moist Heat or Steam Sterilization

[M2482050011]

Moist Heat or Steam Sterilization

[M2482050011]

Moist Heat or Steam Sterilization

[M2482050011]

Moist Heat or Steam Sterilization

[M2482050011]

Moist Heat or Steam Sterilization

[M2482050011]

Moist Heat or Steam Sterilization

[M2482050011]

Moist Heat or Steam Sterilization

[M2482050011]

Moist Heat or Steam Sterilization

[M2482050011]

Moist Heat or Steam Sterilization

[M2482050011]

Moist Heat or Steam Sterilization

[M2482050011]

Moist Heat or Steam Sterilization

[M2482050011]

Moist Heat or Steam Sterilization

[M2482050011]

Moist Heat or Steam Sterilization

[M2482050011]

Moist Heat or Steam Sterilization

[M2482050011]

Moist Heat or Steam Sterilization

[M2482050011]

Moist Heat or Steam Sterilization

[M2482050011]

Moist Heat or Steam Sterilization

[M2482050011]

Moist Heat or Steam Sterilization

[M2482050011]

Moist Heat or Steam Sterilization

[M2482050011]

Moist Heat or Steam Sterilization

[M2482050011]

Moist Heat or Steam Sterilization

[M2482050011]

Moist Heat or Steam Sterilization

[M2482050011]

Moist Heat or Steam Sterilization

[M2482050011]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-10-21
• 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