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
K192192 3D Systems VSP System 02/26/2020
K760960 AMERICAN SAFETY EQUIPMENT CORP. SURGICAL WIRE DRIVER 11/19/1976
K894150 ARTECH CORP. COUNTERBORE FOR SS SUBMERGED SCREW PLANT 09/27/1989
K894151 ARTECH CORP. IRRIGATED DRILL FOR SS SUBMERGED SCREW PLANT 09/27/1989
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
K120956 MEDICAL MODELING INC VSP SYSTEM 12/12/2012
K133907 MEDICAL MODELING INC. VSP SYSTEM 01/22/2014
K871834 MILITARY ENGINEERING, INC. DRILL, HAND, BONE, SMEDBERG 07/31/1987
K781974 MITER, INC. IMPLANT DRIVERS AND TIPS 12/28/1978
K172164 Propel Orthodontics LLC PROPEL Device 01/17/2018
K150392 PROPEL ORTHODONTICS LLC. PROPEL device 09/18/2015
K915848 SENSORMEDICS CORP. SENSORMEDICS MODEL 2450 PULMONARY FUNCTION LAB. 10/28/1992
K943540 STRYKER CORP. SURGICAL CUTTING BURS 11/30/1994
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
K883922 TECHMEDICA, INC. TECHMEDICA I.B.O. BLADE 12/08/1988


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