WristMotion® Wrist Hemiarthroplasty System 8W15-3523-W

GUDID M5288W153523W0

15mm Capitate Component, 35mm x 23mm, Wrist, CE

ARTHROSURFACE INCORPORATED

Carpal lunate prosthesis

• Primary Device ID: M5288W153523W0
• NIH Device Record Key: 8fb4f71b-d4f7-4936-a530-709ba7569ec5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WristMotion® Wrist Hemiarthroplasty System
• Version Model Number: 8W15-3523-W
• Catalog Number: 8W15-3523-W
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M5288W153523W0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141920

FDA Product Code

• KWN: Prosthesis, Wrist, Carpal Lunate

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 [WristMotion® Wrist Hemiarthroplasty System]

• M5288W950016W0: Taper Post, 7.5mm Dia, Capitate, CE
• M5288W153523W0: 15mm Capitate Component, 35mm x 23mm, Wrist, CE
• M5288W153517W0: 15mm Capitate Component, 35mm x 17mm, Wrist, CE
• M5288W152223W0: 15mm Capitate Component, 22mm x 23mm, Wrist, CE
• M5288W152217W0: 15mm Capitate Component, 22mm x 17mm, Wrist, CE
• M5288W123517W0: 12mm Capitate Component, 35mm x 17mm, Wrist, CE
• M5288W122217W0: 12mm Capitate Component, 22mm x 17mm, Wrist, CE