Toe MotionTM 9P15-0100

GUDID M5289P1501000

Insert Delivery Tool, DF-P

ARTHROSURFACE INCORPORATED

Total metatarsophalangeal joint prosthesis, modular Total metatarsophalangeal joint prosthesis, modular Total metatarsophalangeal joint prosthesis, modular Total metatarsophalangeal joint prosthesis, modular Total metatarsophalangeal joint prosthesis, modular Total metatarsophalangeal joint prosthesis, modular Total metatarsophalangeal joint prosthesis, modular Total metatarsophalangeal joint prosthesis, modular Total metatarsophalangeal joint prosthesis, modular Total metatarsophalangeal joint prosthesis, modular Total metatarsophalangeal joint prosthesis, modular Total metatarsophalangeal joint prosthesis, modular Total metatarsophalangeal joint prosthesis, modular Total metatarsophalangeal joint prosthesis, modular Total metatarsophalangeal joint prosthesis, modular

• Primary Device ID: M5289P1501000
• NIH Device Record Key: ad9c5ddd-b446-4b39-98b2-0351acf0dfc1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Toe MotionTM
• Version Model Number: 9P15-0100
• Catalog Number: 9P15-0100
• Company DUNS: 144666109
• Company Name: ARTHROSURFACE INCORPORATED
• 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: 508-520-3003
• Email: contact@arthrosurface.com
• Phone: 508-520-3003
• Email: contact@arthrosurface.com
• Phone: 508-520-3003
• Email: contact@arthrosurface.com
• Phone: 508-520-3003
• Email: contact@arthrosurface.com
• Phone: 508-520-3003
• Email: contact@arthrosurface.com
• Phone: 508-520-3003
• Email: contact@arthrosurface.com
• Phone: 508-520-3003
• Email: contact@arthrosurface.com
• Phone: 508-520-3003
• Email: contact@arthrosurface.com
• Phone: 508-520-3003
• Email: contact@arthrosurface.com
• Phone: 508-520-3003
• Email: contact@arthrosurface.com
• Phone: 508-520-3003
• Email: contact@arthrosurface.com
• Phone: 508-520-3003
• Email: contact@arthrosurface.com
• Phone: 508-520-3003
• Email: contact@arthrosurface.com
• Phone: 508-520-3003
• Email: contact@arthrosurface.com
• Phone: 508-520-3003
• Email: contact@arthrosurface.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M5289P1501000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132496

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: 2021-04-21
• Device Publish Date: 2015-09-16

On-Brand Devices [Toe MotionTM]

• M5289P15S180A0: Fixation Component, DF-P
• M5289P15PB02A0: Modular Insert, 2.5mm Offset -02 (4.6mm thick)
• M5289P15PB01A0: Modular Insert, 2.5mm Offset -01 (3.6mm thick)
• M5289P15PA02A0: Modular Insert, 1.5mm Offset -02 (4.6mm thick)
• M5289P15PA01A0: Modular Insert, 1.5mm Offset -01 (3.6mm thick)
• M5289P1501000: Insert Delivery Tool, DF-P