FDA 510(k) Applications for Medical Device Product Code: JWJ (Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained)

FDA 510(k) Applications for Medical Device Product Code "JWJ"
(Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K200718	Arthrosurface, Inc.	Arthrosurface WristMotion Total Wrist Arthroplasty System	10/15/2020
K021859	AVANTA ORTHOPAEDICS, INC.	WRIST IMPLANT	12/02/2002
K080426	BIOMET MANUFACTURING CORP.	MAESTRO WRIST FRACTURE IMPLANT	07/29/2008
K042032	BIOMET, INC.	MAESTRO TOTAL WRIST	10/07/2004
K031203	DEPUY ORTHOPAEDICS, INC.	BIAX A.F. WRIST/BIAX ADVANCED FIXATION WRIST	07/14/2003
K191525	Extremity Medical, LLC.	KinematX Total Wrist Arthroplasty System	03/04/2020
K132250	INTEGRA LIFE SCIENCES CORPORATION	INTEGRA FREEDOM WRIST ARTHROPLASTY SYSTEM	03/24/2014
K020554	KINETIKOS MEDICAL, INC.	MODIFICATION TO UNIVERSAL TOTAL WRIST SYSTEM	05/03/2002
K030037	KINETIKOS MEDICAL, INC.	UNIVERSAL TOTAL WRIST SYSTEM	02/05/2003
K961051	KINETIKOS MEDICAL, INC.	UNIVERSAL TOTAL WRIST SYSTEM (MODIFICATION)	06/06/1996
K982156	PASCO LABORATORIES, INC.	PASCO MIC AND MIC/ID PANELS/ CEFDINIR	07/29/1998