KGTI™ Kinetik Great Toe Implant System 015090

GUDID M2480150901

PHALANGEAL REAMER

INTEGRA LIFESCIENCES CORPORATION

Bone-resection orthopaedic reamer, reusable

• Primary Device ID: M2480150901
• NIH Device Record Key: de77b5a7-c861-4f3e-9285-42f8aa5bc778
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KGTI™ Kinetik Great Toe Implant System
• Version Model Number: 015090
• Catalog Number: 015090
• 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
• 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	10381780279921 [Primary]
HIBCC	M2480150901 [Secondary]

FDA Product Code

• HTO: REAMER

Sterilization

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

[M2480150901]

Moist Heat or Steam Sterilization

[M2480150901]

Moist Heat or Steam Sterilization

[M2480150901]

Moist Heat or Steam Sterilization

[M2480150901]

Moist Heat or Steam Sterilization

[M2480150901]

Moist Heat or Steam Sterilization

[M2480150901]

Moist Heat or Steam Sterilization

[M2480150901]

Moist Heat or Steam Sterilization

[M2480150901]

Moist Heat or Steam Sterilization

[M2480150901]

Moist Heat or Steam Sterilization

[M2480150901]

Moist Heat or Steam Sterilization

[M2480150901]

Moist Heat or Steam Sterilization

[M2480150901]

Moist Heat or Steam Sterilization

[M2480150901]

Moist Heat or Steam Sterilization

[M2480150901]

Moist Heat or Steam Sterilization

[M2480150901]

Moist Heat or Steam Sterilization

[M2480150901]

Moist Heat or Steam Sterilization

[M2480150901]

Moist Heat or Steam Sterilization

[M2480150901]

Moist Heat or Steam Sterilization

[M2480150901]

Moist Heat or Steam Sterilization

[M2480150901]

Moist Heat or Steam Sterilization

[M2480150901]

Moist Heat or Steam Sterilization

[M2480150901]

Moist Heat or Steam Sterilization

[M2480150901]

Moist Heat or Steam Sterilization

[M2480150901]

Moist Heat or Steam Sterilization

[M2480150901]

Moist Heat or Steam Sterilization

[M2480150901]

Moist Heat or Steam Sterilization

[M2480150901]

Moist Heat or Steam Sterilization

[M2480150901]

Moist Heat or Steam Sterilization

[M2480150901]

Moist Heat or Steam Sterilization

[M2480150901]

Moist Heat or Steam Sterilization

[M2480150901]

Moist Heat or Steam Sterilization

[M2480150901]

Moist Heat or Steam Sterilization

[M2480150901]

Moist Heat or Steam Sterilization

[M2480150901]

Moist Heat or Steam Sterilization

[M2480150901]

Moist Heat or Steam Sterilization

[M2480150901]

Moist Heat or Steam Sterilization

[M2480150901]

Moist Heat or Steam Sterilization

[M2480150901]

Moist Heat or Steam Sterilization

[M2480150901]

Moist Heat or Steam Sterilization

[M2480150901]

Moist Heat or Steam Sterilization

[M2480150901]

Moist Heat or Steam Sterilization

[M2480150901]

Moist Heat or Steam Sterilization

[M2480150901]

Moist Heat or Steam Sterilization

[M2480150901]

Moist Heat or Steam Sterilization

[M2480150901]

Moist Heat or Steam Sterilization

[M2480150901]

Moist Heat or Steam Sterilization

[M2480150901]

Moist Heat or Steam Sterilization

[M2480150901]

Moist Heat or Steam Sterilization

[M2480150901]

Moist Heat or Steam Sterilization

[M2480150901]

Moist Heat or Steam Sterilization

[M2480150901]

Moist Heat or Steam Sterilization

[M2480150901]

Moist Heat or Steam Sterilization

[M2480150901]

Moist Heat or Steam Sterilization

[M2480150901]

Moist Heat or Steam Sterilization

[M2480150901]

Moist Heat or Steam Sterilization

[M2480150901]

Moist Heat or Steam Sterilization

[M2480150901]

Moist Heat or Steam Sterilization

[M2480150901]

Moist Heat or Steam Sterilization

[M2480150901]

Moist Heat or Steam Sterilization

[M2480150901]

Moist Heat or Steam Sterilization

[M2480150901]

Moist Heat or Steam Sterilization

[M2480150901]

Moist Heat or Steam Sterilization

[M2480150901]

Moist Heat or Steam Sterilization

[M2480150901]

Moist Heat or Steam Sterilization

[M2480150901]

Moist Heat or Steam Sterilization

[M2480150901]

Moist Heat or Steam Sterilization

[M2480150901]

Moist Heat or Steam Sterilization

[M2480150901]

Moist Heat or Steam Sterilization

[M2480150901]

Moist Heat or Steam Sterilization

[M2480150901]

Moist Heat or Steam Sterilization

[M2480150901]

Moist Heat or Steam Sterilization

[M2480150901]

Moist Heat or Steam Sterilization

[M2480150901]

Moist Heat or Steam Sterilization

[M2480150901]

Moist Heat or Steam Sterilization

[M2480150901]

Moist Heat or Steam Sterilization

[M2480150901]

Moist Heat or Steam Sterilization

[M2480150901]

Moist Heat or Steam Sterilization

[M2480150901]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-07-23
• Device Publish Date: 2018-04-10

On-Brand Devices [KGTI™ Kinetik Great Toe Implant System]

• M2480150901: PHALANGEAL REAMER
• M2480150801: M/P REAMER
• M2480120161: The KGTI phalangeal component is fixed by means of a stem, which is inserted into the medullary
• M2480120141: The KGTI phalangeal component is fixed by means of a stem, which is inserted into the medullary
• M2480120121: The KGTI phalangeal component is fixed by means of a stem, which is inserted into the medullary
• M2480120071: The KGTI metatarsal implant is spherical and extends from the plantar base of the metatarsal hea
• M2480120061: The KGTI metatarsal implant is spherical and extends from the plantar base of the metatarsal hea
• M2480120051: The KGTI metatarsal implant is spherical and extends from the plantar base of the metatarsal hea
• M2480120041: The KGTI metatarsal implant is spherical and extends from the plantar base of the metatarsal hea
• M2480120021: The KGTI metatarsal implant is spherical and extends from the plantar base of the metatarsal hea