Integra® MOVEMENT® Great Toe System MGT89020MT

GUDID 10381780116424

The Integra Movement Great Toe System metatarsal component is designed for resurfacing the 1st metatarsal head. The component is an anatomically designed, monolithic device.The device is made from cobalt chromium alloy with a commercially pure titanium plasma spray. The metatarsal is intended as hemi-arthroplasty at the surface and is a press-fit.

Ascension Orthopedics, Inc.

Total metatarsophalangeal joint prosthesis, one-piece

• Primary Device ID: 10381780116424
• NIH Device Record Key: 9626e496-ccf0-4c30-ad9f-c83434a3d475
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Integra® MOVEMENT® Great Toe System
• Version Model Number: MGT89020MT
• Catalog Number: MGT89020MT
• 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: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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

Device Dimensions

• 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 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 Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780116424 [Primary]
HIBCC	M268MGT89020MT1 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092047

FDA Product Code

• KWD: PROSTHESIS, TOE, HEMI-, PHALANGEAL

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-04-21
• Device Publish Date: 2017-10-09

On-Brand Devices [Integra® MOVEMENT® Great Toe System]

• 10381780119920: The Integra Movement Great Toe System total arthroplasty is an anatomically designed, semi-const
• 10381780119913: The Integra Movement Great Toe System total arthroplasty is an anatomically designed, semi-const
• 10381780119906: The Integra Movement Great Toe System total arthroplasty is an anatomically designed, semi-const
• 10381780119890: The Integra Movement Great Toe System total arthroplasty is an anatomically designed, semi-const
• 10381780116462: The Integra Movement Great Toe System metatarsal component is designed for resurfacing the 1st m
• 10381780116448: The Integra Movement Great Toe System metatarsal component is designed for resurfacing the 1st m
• 10381780116424: The Integra Movement Great Toe System metatarsal component is designed for resurfacing the 1st m
• 10381780116400: The Integra Movement Great Toe System metatarsal component is designed for resurfacing the 1st m
• 10381780116479: The Integra Movement Great Toe System phalangeal component is designed for resurfacing the base
• 10381780116455: The Integra Movement Great Toe System phalangeal component is designed for resurfacing the base
• 10381780116431: The Integra Movement Great Toe System phalangeal component is designed for resurfacing the base
• 10381780116417: The Integra Movement Great Toe System phalangeal component is designed for resurfacing the base