FDA 510(k) Applications for Medical Device Product Code: KXA (Prosthesis, Hip, Femoral, Resurfacing)

FDA 510(k) Applications for Medical Device Product Code "KXA"
(Prosthesis, Hip, Femoral, Resurfacing)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K201219	BioCore9 LLC	Biocore9 Femoral Head Resurfacing Component	01/19/2021
K021799	BIOMET ORTHOPEDICS, INC.	CEMENTED FEMORAL HEAD RESURFING DEVICE	06/26/2002
K023188	BIOMET ORTHOPEDICS, INC.	PRESS-FIT HEAD RESURFACING DEVICE	12/11/2002
K983452	BIOMET, INC.	NELSON RESURFACING HEAD	12/03/1998
K071053	BIOMET, INC.	RECAP HA PRESS-FIT FEMORAL RESURFACING HEAD	06/29/2007
K043542	BIOPRO, INC.	BIOPRO TARA FEMORAL RESURFACING COMPONENT	05/18/2005
K994153	CORIN U.S.A.	CORMET 2000 HEMI HIP METALLIC RESURFACING PROSTHESIS	02/25/2000
K092198	CORIN USA	CORMET CEMENTLESS RESURFACING FEMORAL HEAD	04/15/2010
K032659	DEPUY ORTHOPAEDICS, INC.	DEPUY ASR RESURFACING FEMORAL HEADS	12/04/2003
K021549	STD MFG., INC.	CONTOURED ARTICULAR PROSTHESIS (CAP) FEMORAL HEAD RESURFACING SYSTEM	08/01/2002
K062960	WRIGHT MEDICAL TECHNOLOGY, INC.	CONSERVE FEMORAL RESURFACING COMPONENT	12/01/2006
K082673	WRIGHT MEDICAL TECHNOLOGY, INC.	CONSERVE PRESSFIT FEMORAL COMPONENT	12/12/2008
K070292	ZIMMER GMBH	DUROM HIP RESURFACING SYSTEM, FEMORAL COMPONENTS	04/26/2007