RevoMotion

GUDID M5288RC150080

ARTHROSURFACE INCORPORATED

Total reverse shoulder prosthesis Total reverse shoulder prosthesis Total reverse shoulder prosthesis Total reverse shoulder prosthesis Total reverse shoulder prosthesis Total reverse shoulder prosthesis Total reverse shoulder prosthesis Total reverse shoulder prosthesis Total reverse shoulder prosthesis Total reverse shoulder prosthesis Total reverse shoulder prosthesis Total reverse shoulder prosthesis Total reverse shoulder prosthesis Total reverse shoulder prosthesis Total reverse shoulder prosthesis Total reverse shoulder prosthesis Total reverse shoulder prosthesis Total reverse shoulder prosthesis

• Primary Device ID: M5288RC150080
• NIH Device Record Key: d1284de2-7f15-4d72-8d6e-c33356c62cf7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RevoMotion
• Version Model Number: 8RC1-5008
• 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	M5288RC150080 [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