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KIJ — Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment Class I

FDA Device Classification

Classification Details

Product Code
KIJ
Device Class
Class I
Regulation Number
878.4820
Submission Type
Review Panel
OR
Medical Specialty
General, Plastic Surgery
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K163308jeil medical corporationSMARTODecember 27, 2016
K112599insurgicalINSURGICAL SINGLE USE POWER EQUIPMENTNovember 6, 2012
K101563jeil medical corporationSMARTODecember 17, 2010
K972367stryker instrumentsSTRYKER SYSTEM 4000 HEAVY DUTY BATTERY POWERED EQUIPMENTSeptember 4, 1997
K970378implant resourceSTRYKER 2115 REPLACEMENT BATTERY (2115)April 30, 1997
K960711acu medACUMED BONE GRAFT SYSTEMMay 7, 1996
K951450strenumedSYSTEM 2000 REPLACEMENT BATTERY, SYSTEM 2000-EXTENDED RUN REPLACEMENT BATTERYMay 17, 1995
K944488s and s orthopedicS & S ORTHOPEDIC WIRE DRIVER 701March 2, 1995
K941285arthrexARTHREX GRAFT HARVESTING KITNovember 14, 1994
K933101osteomedTHE OSTEOMED B POWER SYSTEM AND ACCESSORIESNovember 7, 1994
K933337r and d batteriesR AND D BATTERY REPLACEMENTApril 5, 1994
K931395micro surgical instrumentsSERIES 5000 BATTERY POWERED INSTRUMENT SYSTEMJanuary 28, 1994
K9323073m health care3M MAXI-DRIVER II DBATTERY POWERED SYSTEMJanuary 7, 1994
K884839dyonicsMODIFIED SAW BLADES TO THE SAGITAL SAWDecember 7, 1988
K873766bowen and companySTERNAL POWER AWLNovember 14, 1988
K864137bio-radLYPHOCHEK IMMUNOASSAY SERUM CONTROL LEVEL I,II,IIINovember 7, 1986
K850789t. korossurgical instrumentsFLUTED SUCTION MENISCAL CUTTERJune 28, 1985
K844162aeg power toolEZ 505March 11, 1985
K844163aeg power toolEZ 502March 11, 1985
K822790xomedMICRO-CRAFT OSCILLATING SAW HANDPIECEOctober 22, 1982