BOSS Toe Fixation System 9CRS-D100-A

GUDID M5289CRSD100A0

Taper Post, BOSS, 10.0mm (20.0mm LG)

ARTHROSURFACE INCORPORATED

Partial metatarsophalangeal joint prosthesis

• Primary Device ID: M5289CRSD100A0
• NIH Device Record Key: 056f36dd-2908-459f-8509-880261debae6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BOSS Toe Fixation System
• Version Model Number: 9CRS-D100-A
• Catalog Number: 9CRS-D100-A
• 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: true
• 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
• Phone: 508-520-3003
• Email: contact@arthrosurface.com
• Phone: 508-520-3003
• Email: contact@arthrosurface.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M5289CRSD100A0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190261

FDA Product Code

• KWD: Prosthesis, Toe, Hemi-, Phalangeal

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-04-08
• Device Publish Date: 2020-03-31

On-Brand Devices [BOSS Toe Fixation System]

• M5289CRSD100A0: Taper Post, BOSS, 10.0mm (20.0mm LG)
• M5289CRSD200A0: Taper Post, BOSS, 10.0mm (18.5mm LG)