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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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