RevoMotion

GUDID M5288RS210400

ARTHROSURFACE INCORPORATED

Total reverse shoulder prosthesis

• Primary Device ID: M5288RS210400
• NIH Device Record Key: 69ba7253-fd3a-46d1-9465-b3c5b57f2490
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RevoMotion
• Version Model Number: 8RS2-1040
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M5288RS210400 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203375

FDA Product Code

• PHX: Shoulder Prosthesis, Reverse Configuration

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: 2024-04-22
• Device Publish Date: 2024-04-12

On-Brand Devices [RevoMotion]

• M5288RS410250: 8RS4-1025
• M5288RS410200: 8RS4-1020
• M5288RS210450: 8RS2-1045
• M5288RS210400: 8RS2-1040
• M5288RS210350: 8RS2-1035
• M5288RS210300: 8RS2-1030
• M5288RS210250: 8RS2-1025
• M5288RS210200: Center Screw, Ø 6.5mm x 20mm
• M5288RG232000: Glenosphere, 32mm, +2 Lateral Offset
• M5288RC150080: 8RC1-5008