Integra® MOVEMENT® Great Toe System MGT89030PPT

GUDID 10381780119913

The Integra Movement Great Toe System total arthroplasty is an anatomically designed, semi-constrained, two-piece device designed for resurfacing of the base of the 1st metatarso-phalangeal (MTP) joint. The device uses the metatarsal hemi arthroplasty device paired with a phalangeal base manufactured from titanium with a UHMWPE articulating surface insert. The phalangeal joint replacement device is intended for cemented use.

Ascension Orthopedics, Inc.

Partial metatarsophalangeal joint prosthesis

• Primary Device ID: 10381780119913
• NIH Device Record Key: 883002d8-56d9-47be-a251-08e7a1d9d3fe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Integra® MOVEMENT® Great Toe System
• Version Model Number: MGT89030PPT
• Catalog Number: MGT89030PPT
• 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: false
• 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
• 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	10381780119913 [Primary]
HIBCC	M268MGT89030PPT1 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102549

FDA Product Code

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

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: 2020-10-02
• Device Publish Date: 2015-09-22

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