KGTI™

GUDID M248KGTISET1

KGTI™ Instrument Set (01-5000)

Ascension Orthopedics, Inc.

Partial metatarsophalangeal joint prosthesis

• Primary Device ID: M248KGTISET1
• NIH Device Record Key: d61a8637-8485-4a80-bfb9-890117324cde
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KGTI™
• Version Model Number: KGTISET
• Company DUNS: 942377524
• Company Name: Ascension Orthopedics, Inc.
• 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780257264 [Primary]
HIBCC	M248KGTISET1 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K924724

FDA Product Code

• LZJ: PROSTHESIS, TOE (METATARSOPHALANGEAL), JOINT, METAL/POLYMER, SEMI-CONSTRAINED

Sterilization

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

[M248KGTISET1]

Moist Heat or Steam Sterilization

[M248KGTISET1]

Moist Heat or Steam Sterilization

[M248KGTISET1]

Moist Heat or Steam Sterilization

[M248KGTISET1]

Moist Heat or Steam Sterilization

[M248KGTISET1]

Moist Heat or Steam Sterilization

[M248KGTISET1]

Moist Heat or Steam Sterilization

[M248KGTISET1]

Moist Heat or Steam Sterilization

[M248KGTISET1]

Moist Heat or Steam Sterilization

[M248KGTISET1]

Moist Heat or Steam Sterilization

[M248KGTISET1]

Moist Heat or Steam Sterilization

[M248KGTISET1]

Moist Heat or Steam Sterilization

[M248KGTISET1]

Moist Heat or Steam Sterilization

[M248KGTISET1]

Moist Heat or Steam Sterilization

[M248KGTISET1]

Moist Heat or Steam Sterilization

[M248KGTISET1]

Moist Heat or Steam Sterilization

[M248KGTISET1]

Moist Heat or Steam Sterilization

[M248KGTISET1]

Moist Heat or Steam Sterilization

[M248KGTISET1]

Moist Heat or Steam Sterilization

[M248KGTISET1]

Moist Heat or Steam Sterilization

[M248KGTISET1]

Moist Heat or Steam Sterilization

[M248KGTISET1]

Moist Heat or Steam Sterilization

[M248KGTISET1]

Moist Heat or Steam Sterilization

[M248KGTISET1]

Moist Heat or Steam Sterilization

[M248KGTISET1]

Moist Heat or Steam Sterilization

[M248KGTISET1]

Moist Heat or Steam Sterilization

[M248KGTISET1]

Moist Heat or Steam Sterilization

[M248KGTISET1]

Moist Heat or Steam Sterilization

[M248KGTISET1]

Moist Heat or Steam Sterilization

[M248KGTISET1]

Moist Heat or Steam Sterilization

[M248KGTISET1]

Moist Heat or Steam Sterilization

[M248KGTISET1]

Moist Heat or Steam Sterilization

[M248KGTISET1]

Moist Heat or Steam Sterilization

[M248KGTISET1]

Moist Heat or Steam Sterilization

[M248KGTISET1]

Moist Heat or Steam Sterilization

[M248KGTISET1]

Moist Heat or Steam Sterilization

[M248KGTISET1]

Moist Heat or Steam Sterilization

[M248KGTISET1]

Moist Heat or Steam Sterilization

[M248KGTISET1]

Moist Heat or Steam Sterilization

[M248KGTISET1]

Moist Heat or Steam Sterilization

[M248KGTISET1]

Moist Heat or Steam Sterilization

[M248KGTISET1]

Moist Heat or Steam Sterilization

[M248KGTISET1]

Moist Heat or Steam Sterilization

[M248KGTISET1]

Moist Heat or Steam Sterilization

[M248KGTISET1]

Moist Heat or Steam Sterilization

[M248KGTISET1]

Moist Heat or Steam Sterilization

[M248KGTISET1]

Moist Heat or Steam Sterilization

[M248KGTISET1]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-03-04
• Device Publish Date: 2016-07-25

Devices Manufactured by Ascension Orthopedics, Inc.

• M268TIWEDGEINSTP1 - TiWedgeTM: 2023-11-13 The Integra Titanium Bone Wedge is intended to be used for internal bone fixation for bone fractures or osteotomies in the ankle
• M269AW32051 - CAPTURE™: 2023-11-09 CAPTURE™ High Torque Screw System The cannula cleaning stylet is used to clean all cannulated instruments. This instrument is
• 10381780123026 - CAPTURE™ High Torque Screw System: 2023-09-18 The washer is used in conjunction with the Capture High Torque Screw System.
• 10381780123033 - CAPTURE™ High Torque Screw System: 2023-09-18 The washer is used in conjunction with the Capture High Torque Screw System.
• 10381780123040 - CAPTURE™ High Torque Screw System: 2023-09-18 The washer is used in conjunction with the Capture High Torque Screw System.
• 10381780123057 - CAPTURE™ High Torque Screw System: 2023-09-18 The washer is used in conjunction with the Capture High Torque Screw System.
• 10381780123064 - CAPTURE™ High Torque Screw System: 2023-09-18 The washer is used in conjunction with the Capture High Torque Screw System.
• M26922286111 - Integra®: 2023-09-18 Integra® Total Foot System K-Wire is used for temporary fixation.