FDA 510(k) Applications for Medical Device Product Code: KXE (Prosthesis, Wrist, Hemi-, Ulnar)

FDA 510(k) Applications for Medical Device Product Code "KXE"
(Prosthesis, Wrist, Hemi-, Ulnar)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K190599	Aptis Medical, LLC	Aptis Medical Distal Radio Ulnar Joint Implant	05/03/2019
K142569	APTIS MEDICAL, LLC.	Aptis Medical Distal Radio Ulnar Joint Implant	04/03/2015
K082839	APTIS MEDICAL, LLC.	DISTAL RADIO-ULNAR JOINT IMPLANT	10/24/2008
K053119	APTIS MEDICAL, LLC.	DISTAL RADIO-ULNAR JOINT IMPLANT	12/07/2005
K040497	APTIS MEDICAL, LLC.	DISTAL RADIO-ULNAR JOINT IMPLANT	01/26/2005
K112481	ASCENSION ORTHOPEDIC	FIRST CHOICE DRUJ SYSTEM, PARTIAL HEAD IMPLANT	04/09/2012
K052137	ASCENSION ORTHOPEDICS, INC.	ASCENSION MUH	11/03/2005
K010786	AVANTA ORTHOPAEDICS, INC.	ULNAR HEAD IMPLANT	04/11/2001
K982268	AVANTA ORTHOPAEDICS, INC.	ULNAR HEAD IMPLANT	12/04/1998
K033930	KAPP SURGICAL INSTRUMENT, INC.	KAPP CUSTOM ULNAR HEAD WRIST IMPLANT	07/28/2004
K081025	REMI SCIENCES, INC.	ISOELASTICU	11/21/2008
K061146	SMALL BONE INNOVATIONS INC.	SBI ULNAR HEAD IMPLANT	07/19/2006
K042902	STUCKENBROCK MEDIZINTECHNIK GMBH	HERBERT ULNAR HEAD PROSTHESIS SYSTEM	12/27/2004
K020274	WRIGHT MEDICAL TECHNOLOGY, INC.	WMT MODULAR ULNAR HEAD IMPLANT	02/22/2002