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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.
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