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KXA — Prosthesis, Hip, Femoral, Resurfacing Class II

FDA Device Classification

Classification Details

Product Code
KXA
Device Class
Class II
Regulation Number
888.3400
Submission Type
Review Panel
OR
Medical Specialty
Orthopedic
Implant
Yes

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K201219biocore9Biocore9 Femoral Head Resurfacing ComponentJanuary 19, 2021
K092198corin usaCORMET CEMENTLESS RESURFACING FEMORAL HEADApril 15, 2010
K082673wrightmedicaltechnologyincCONSERVE PRESSFIT FEMORAL COMPONENTDecember 12, 2008
K071053biometRECAP HA PRESS-FIT FEMORAL RESURFACING HEADJune 29, 2007
K070292zimmerDUROM HIP RESURFACING SYSTEM, FEMORAL COMPONENTSApril 26, 2007
K062960wrightmedicaltechnologyincCONSERVE FEMORAL RESURFACING COMPONENTDecember 1, 2006
K043542bioproBIOPRO TARA FEMORAL RESURFACING COMPONENTMay 18, 2005
K032659depuy orthopaedicsDEPUY ASR RESURFACING FEMORAL HEADSDecember 4, 2003
K023188biomet orthopedicsPRESS-FIT HEAD RESURFACING DEVICEDecember 11, 2002
K021549std mfgCONTOURED ARTICULAR PROSTHESIS (CAP) FEMORAL HEAD RESURFACING SYSTEMAugust 1, 2002
K021799biomet orthopedicsCEMENTED FEMORAL HEAD RESURFING DEVICEJune 26, 2002
K994153corin usaCORMET 2000 HEMI HIP METALLIC RESURFACING PROSTHESISFebruary 25, 2000
K983452biometNELSON RESURFACING HEADDecember 3, 1998
K950998intermedics orthopedicsMODUILAR UNIPOLARApril 13, 1995
K944752orthometORTHOMET RESURFACING FEMORAL COMPONENTDecember 28, 1994
K904870endotecMODIFIED NEW JERSEY FEMORAL HIP RESURFACING COMPONMay 23, 1991
K894604bioproBIOPRO PROXIMAL FEMORAL ARTICULAR REPLACEMENTNovember 17, 1989
K892398orthometBIPOLAR HIP SYSTEMMay 23, 1989
K883212implant technologyLSF (R) TOTAL HIP SYSTEM - BIPOLAR COMPONENTNovember 22, 1988
K842233endomedicsNEW JERSEY FEMORAL RESURFACING COMPONENTJuly 20, 1984