TrueBalance™ Surgical System

Intraoperative Orthopedic Joint Assessment Aid

These Three Medical, LLC

The following data is part of a premarket notification filed by These Three Medical, Llc with the FDA for Truebalance™ Surgical System.

Pre-market Notification Details

• Device ID: K220830
• 510k Number: K220830
• Device Name: TrueBalance™ Surgical System
• Classification: Intraoperative Orthopedic Joint Assessment Aid
• Applicant: These Three Medical, LLC 20860 N. Tatum Blvd., Suite 300 Phoenix, AZ 85050
• Contact: Moj Eram
• Correspondent: Moj Eram; These Three Medical, LLC 20860 N. Tatum Blvd., Suite 300 Phoenix, AZ 85050
• Product Code: ONN
• CFR Regulation Number: 882.4560 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2022-03-22
• Decision Date: 2022-09-15