FDA 510(k) Applications for Medical Device Product Code: DZJ (Driver, Wire, And Bone Drill, Manual)

FDA 510(k) Applications for Medical Device Product Code "DZJ"
(Driver, Wire, And Bone Drill, Manual)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K220366	3D LifePrints UK Ltd.	EmbedMed	09/30/2022
K192192	3D Systems	VSP System	02/26/2020
K210347	3D Systems	VSP System	04/26/2021
K201353	CenterMed, Inc.	CenterMed Patient Matched Assisted Surgical Planning (ASP) System	06/28/2021
K193301	Dental Wings GmbH	coDiagnostiX	06/21/2021
K181813	ImmersiveTouch	ImmersiveView Surgical Plan (IVSP«)	06/09/2020
K182789	KLS-Martin L.P.	KLS Martin Individual Patient Solutions (IPS) Planning System	03/11/2019
K181241	KLS-Martin L.P.	KLS Martin Individual Patient Solutions (IPS) Planning System	09/13/2018
K243637	Materialise NV	Materialise Personalized Guides and Models for Craniomaxillofacial Surgery	02/21/2025
K223024	MedCAD	MedCAD AccuPlan System	03/07/2023
K192282	MedCAD	MedCAD« AccuPlan« System	10/29/2020
K120956	MEDICAL MODELING INC	VSP SYSTEM	12/12/2012
K133907	MEDICAL MODELING INC.	VSP SYSTEM	01/22/2014
K212570	OsteoMed LLC	OsteoPlan System	02/11/2022
K172164	Propel Orthodontics LLC	PROPEL Device	01/17/2018
K150392	PROPEL ORTHODONTICS LLC.	PROPEL device	09/18/2015
K193499	ProtoMED, Inc.	DigiGuide System	11/04/2020
K040369	STRYKER INSTRUMENTS	STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM	04/01/2004
K150796	SYNTHES (USA) PRODUCTS, LLC	Dental Bone Cutting Instruments	06/23/2015
K230276	TECHFIT Digital Surgery	TECHFIT DISRP« System	06/23/2023
K242263	TECHFIT Digital Surgery Inc.	TECHFIT DISRP« System	12/11/2024
K231520	TechMah CMF	tmCMF Solution	10/02/2023
K220648	VHA DEAN	OMF ASP System	08/11/2022