FDA 510(k) Applications for Medical Device Product Code: JDB (Prosthesis, Elbow, Semi-Constrained, Cemented)

FDA 510(k) Applications for Medical Device Product Code "JDB"
(Prosthesis, Elbow, Semi-Constrained, Cemented)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K972691	BIOMET, INC.	ABC TOTAL ELBOW PROTHESIS	10/15/1997
K983141	JOHNSON & JOHNSON PROFESSIONALS, INC.	CAPITELLO-CONDYLAR TOTAL ELBOW PROSTHESIS	11/06/1998
K222807	LimaCorporate S.p.A.	TEMA Elbow system - Line extension	10/26/2022
K060038	SMALL BONE INNOVATIONS INC.	SBI RADIO-CAPITELLAR IMPLANT	03/30/2006
K102180	SMALL BONE INNOVATIONS, INC.	RHEAD RADIAL HEAD EXTENDED STEMS	12/20/2010
K070236	SMALL BONE INNOVATIONS, INC.	SBI LATERAL RADIO CAPITELLUM	02/21/2007
K070787	TORNIER	LATITUDE ELBOW PROTHESIS	08/24/2007
K031218	TORNIER	MODIFICATION TO TORNIER TOTAL ELBOW PROSTHESIS	05/16/2003
K060438	TORNIER	RHS	04/18/2006
K050848	TORNIER	TORNIER ELBOW PROSTHESIS	07/14/2005
K011567	TORNIER	TORNIER TOTAL ELBOW PROSTHESIS	06/19/2001
K171010	Tornier Inc.	Latitude EV Total Elbow Arthroplasty	08/31/2017
K182461	Tornier Inc.	LATITUDE EV Total Elbow Arthroplasty	12/27/2018
K193247	Tornier Inc.	LATITUDE EVÖ Total Elbow Arthroplasty	08/05/2020
K100562	TORNIER, INC.	LATITUDE ELBOW PROSTHESIS	06/29/2010
K955099	WRIGHT MEDICAL TECHNOLOGY, INC.	SORBIE TOTAL ELBOW SYSTEM	02/05/1996
K960087	WRIGHT MEDICAL TECHNOLOGY, INC.	SORIBIE RESURFACING TOTAL ELBOW SYSTEM (PROPOSED NAME)	09/20/1996