FDA 510(k) Applications for Medical Device Product Code: QHE ()

FDA 510(k) Applications for Medical Device Product Code "QHE"

FDA 510(k) Number	Applicant	Device Name	Decision Date
K222007	Arthrex Inc.	Arthrex Virtual Implant Positioning (VIP) System	03/08/2023
K230904	Arthrex Inc.	Arthrex Virtual Implant Positioning (VIP) System	06/22/2023
K222405	LimaCorporate S.p.A	Smart SPACE Shoulder Planner and 3D Positioners	12/20/2022
K193560	Materialise NV	Materialise Shoulder Guide and Models, Materialise SurgiCase Shoulder Planner, Materialise Shoulder Planner, SurgiCase Shoulder Planner, SurgiCase Planner	03/20/2020
K230315	Materialise NV	Materialise Shoulder SystemÖ Materialise Shoulder Guide and Models SurgiCase Shoulder Planner	03/06/2023
K212569	Materialise NV	Materialise Shoulder SystemÖ, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner	01/12/2022
K231112	Materialise NV	Materialise Shoulder SystemÖ, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner	09/12/2023
K220452	Materialise NV	Materialise Shoulder SystemTM Materialise Shoulder Guide and Models SurgiCase Shoulder Planner	08/17/2022
K200615	Orthosoft Inc. (d/b/a Zimmer CAS)	Signature ONE System	06/05/2020
K212560	Orthosoft Inc. (d/b/a Zimmer CAS)	SignatureÖ ONE System	10/12/2021
K192074	Orthosoft, Inc. (d/b/a Zimmer CAS)	Signature ONE System	08/30/2019
K202151	TechMah Medical LLC	Smart SPACE Shoulder System	02/03/2021
K202454	TechMah Medical LLC	Smart SPACE Shoulder System	12/28/2020