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
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
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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