FDA 510(k) Applications Submitted by CUSTOM ORTHOPAEDIC SOLUTIONS, INC.

FDA 510(k) Number Submission Date Device Name Applicant
K142072 07/23/2014 GLENOID INTELLIGENT REUSABLE INSTRUMENT SYSTEM (GLENOID IRIS) CUSTOM ORTHOPAEDIC SOLUTIONS, INC.
K162697 09/27/2016 Arthrex Glenoid Intelligent Reusable Instrument System, Arthrex OrthoVis Preoperative Plan, SmartBase for Arthrex Glenoid IRIS, ArthrexVIP Web Portal Custom Orthopaedic Solutions, Inc.
K153215 11/05/2015 SmartBase for Arthrex Glenoid IRIS Custom Orthopaedic Solutions, Inc.
K153612 12/17/2015 ArthrexVIP Web Portal CUSTOM ORTHOPAEDIC SOLUTIONS, INC.
K151568 06/10/2015 Arthrex OrthoVis Preoperative Plan Custom Orthopaedic Solutions, Inc.


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact