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HWE — Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment Class I

FDA Device Classification

Classification Details

Product Code
HWE
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
K143191mcginley innovationsIntelliSense DrillFebruary 20, 2015
K102743ortho solutions limitedORTHO SOLUTIONS - STERILE, DRILLS, TAPS, GUIDE PINS & WIRESJanuary 20, 2011
K063688anspach effortSURGICAL IRRIGATION SYSTEM, IRRIGATION TUBEJanuary 16, 2007
K050766zimmer trabecularEXPLANT OSTEONECROSIS INTERVENTION IMPLANT REMOVAL SYSTEMMay 26, 2005
K043310synthes (usa)SYNTHES (USA) ELECTRIC PEN DRIVE SYSTEMJanuary 5, 2005
K022744medical device servicesREPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURSSeptember 18, 2002
K012676adven medicalREPROCESSED USED, DISPOSABLE BLADES, BURS, BITS AND TAPSFebruary 4, 2002
K012694adven medicalREPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURSFebruary 4, 2002
K990816modular cutting systemsAVCORE SYSTEMSeptember 24, 1999
K973736aesculapAESCULAP HILAN MOTOR SYSTEMDecember 29, 1997
K973560ds mfgBONE GRAFT HARVESTERNovember 12, 1997
K972508synvasive technologySURGICAL BURS AND SURGICAL DRILL BITSAugust 26, 1997
K971342disk whiskDISK WHISK CUTTING DEVICE (CONICAL, ELLIPTICAL AND BALL HEAD)July 8, 1997
K971544synthes (usa)SYNTHES (USA) COMPACT AIR DRIVE II (CAD II)May 28, 1997
K962087mediconSERVOTRONIC EC100 SYSTEMApril 23, 1997
K970088richard wolf medical instrumentsRIWO DRIVE WITH FOOTSWITCH/MOTOR HANDLE, COOMPLETE,6000RPM/3000RPM/ROTARY BLADESApril 7, 1997
K970023mednextMEDNEXT SURGICAL BURFebruary 28, 1997
K970040spine-techSPINE-TECH BONE HARVESTERFebruary 28, 1997
K962913synthes (usa)SYNTHES STERILE DRILL BITSNovember 14, 1996
K962800stryker instrumentsSTRYKER UNIVERSAL DRILL ATTACHMENTS & ACCESSORIESSeptember 11, 1996