FDA 510(k) Applications Submitted by Paul Hardy

FDA 510(k) Number Submission Date Device Name Applicant
K210653 03/04/2021 ONE Planner Hip Orthosoft d/b/a Zimmer CAS
K190595 03/07/2019 Signature ONE System Orthosoft Inc. (d/b/a Zimmer CAS)
K220733 03/14/2022 OptiVu ROSA MxR Orthosoft, Inc. (d/b/a Zimmer CAS)
K210998 04/02/2021 ROSA Hip System Orthosoft d/b/a Zimmer CAS
K231103 04/19/2023 ROSA ONE Brain Application Medtech S.A.S
K192074 08/02/2019 Signature ONE System Orthosoft, Inc. (d/b/a Zimmer CAS)
K162559 09/14/2016 Move Forward 3D Motion Simulation Service BIOMET INC.
K213033 09/21/2021 iASSIST Knee System Orthosoft d/b/a Zimmer CAS
K213708 11/24/2021 ROSA« Knee System Orthosoft, Inc (d/b/a Zimmer CAS)
K183544 12/20/2018 Efficient Care 3D Planning Orthosoft, Inc. (d/b/a Zimmer CAS)
K214065 12/27/2021 ROSA ONE Brain application Medtech S.A.S


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