KGTI™ Kinetik Great Toe Implant System 015114

GUDID M2480151141

TRIAL SIZE 2 PHALANGEAL

Ascension Orthopedics, Inc.

Orthopaedic prosthesis implantation instrument, reusable

• Primary Device ID: M2480151141
• NIH Device Record Key: f7286cdb-4b81-4da3-a575-9b0a0c0074c2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KGTI™ Kinetik Great Toe Implant System
• Version Model Number: 015114
• Catalog Number: 015114
• Company DUNS: 942377524
• Company Name: Ascension Orthopedics, Inc.
• 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

Device Dimensions

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Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780279983 [Primary]
HIBCC	M2480151141 [Secondary]

FDA Product Code

• LXH: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Sterilization

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

[M2480151141]

Moist Heat or Steam Sterilization

[M2480151141]

Moist Heat or Steam Sterilization

[M2480151141]

Moist Heat or Steam Sterilization

[M2480151141]

Moist Heat or Steam Sterilization

[M2480151141]

Moist Heat or Steam Sterilization

[M2480151141]

Moist Heat or Steam Sterilization

[M2480151141]

Moist Heat or Steam Sterilization

[M2480151141]

Moist Heat or Steam Sterilization

[M2480151141]

Moist Heat or Steam Sterilization

[M2480151141]

Moist Heat or Steam Sterilization

[M2480151141]

Moist Heat or Steam Sterilization

[M2480151141]

Moist Heat or Steam Sterilization

[M2480151141]

Moist Heat or Steam Sterilization

[M2480151141]

Moist Heat or Steam Sterilization

[M2480151141]

Moist Heat or Steam Sterilization

[M2480151141]

Moist Heat or Steam Sterilization

[M2480151141]

Moist Heat or Steam Sterilization

[M2480151141]

Moist Heat or Steam Sterilization

[M2480151141]

Moist Heat or Steam Sterilization

[M2480151141]

Moist Heat or Steam Sterilization

[M2480151141]

Moist Heat or Steam Sterilization

[M2480151141]

Moist Heat or Steam Sterilization

[M2480151141]

Moist Heat or Steam Sterilization

[M2480151141]

Moist Heat or Steam Sterilization

[M2480151141]

Moist Heat or Steam Sterilization

[M2480151141]

Moist Heat or Steam Sterilization

[M2480151141]

Moist Heat or Steam Sterilization

[M2480151141]

Moist Heat or Steam Sterilization

[M2480151141]

Moist Heat or Steam Sterilization

[M2480151141]

Moist Heat or Steam Sterilization

[M2480151141]

Moist Heat or Steam Sterilization

[M2480151141]

Moist Heat or Steam Sterilization

[M2480151141]

Moist Heat or Steam Sterilization

[M2480151141]

Moist Heat or Steam Sterilization

[M2480151141]

Moist Heat or Steam Sterilization

[M2480151141]

Moist Heat or Steam Sterilization

[M2480151141]

Moist Heat or Steam Sterilization

[M2480151141]

Moist Heat or Steam Sterilization

[M2480151141]

Moist Heat or Steam Sterilization

[M2480151141]

Moist Heat or Steam Sterilization

[M2480151141]

Moist Heat or Steam Sterilization

[M2480151141]

Moist Heat or Steam Sterilization

[M2480151141]

Moist Heat or Steam Sterilization

[M2480151141]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2021-03-04
• Device Publish Date: 2018-04-10

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

• M2480150541: METATARSAL BROACH LEFT POWER
• M2480150521: METATARSAL BROACH RIGHT POWER
• M2480151161: TRIAL SIZE 3 PHALANGEAL
• M2480151141: TRIAL SIZE 2 PHALANGEAL
• M2480151121: TRIAL SIZE 1 PHALANGEAL
• M2480151101: TRIAL SIZE 0 PHALANGEAL
• M2480151061: TRIAL SIZE 3 METATARSAL
• M2480151041: TRIAL SIZE 2 METATARSAL
• M2480151021: TRIAL SIZE 1 METATARSAL
• M2480150701: METATARSAL IMPACTOR
• M2480150551: METATARSAL BROACH LEFT MANUAL
• M2480150531: METATARSAL BROACH RIGHT MANUAL
• M2480150431: METATARSAL BROACH GUIDE LEFT
• M2480150411: METATARSAL BROACH GUIDE RIGHT
• M2480150321: DORSAL FLANGE RESECTION GUIDE
• M2480150221: PHALANGEAL SIZER DRILL GUIDE
• M2480150201: METATARSAL SIZER DRILL GUIDE
• M2480150141: INSTRUMENT HANDLE 90º
• M2480150101: INSTRUMENT HANDLE SMALL
• M2480150041: PRIMARY RESECTION GUIDE 5MM
• M2480150021: PRIMARY RESECTION GUIDE NEUTRAL
• M2480150011: KGTI STERILIZATION CASE
• M2480120101: The KGTI phalangeal component is fixed by means of a stem, which is inserted into the medullary
• M2480120031: The KGTI metatarsal implant is spherical and extends from the plantar base of the metatarsal hea