FDA 510(k) Applications for Medical Device Product Code: MBL (Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous)

FDA 510(k) Applications for Medical Device Product Code "MBL"
(Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K201157	MicroPort Orthopedics Inc.	Prime BIOFOAM« Multi-Hole Shells	08/24/2021
K960094	SMITH & NEPHEW RICHARDS, INC.	REFLECTION DUAL DIMENSION SHELL	03/27/1996
K093363	SMITH & NEPHEW, INC.	COCR AND OXINIUM FEMORAL HEADS AND R3 XLPE LINERS	01/26/2010
K161233	SMITH & NEPHEW, INC.	OXINIUM DH Fermoral Heads	12/14/2016
K182535	Smith & Nephew, Inc.	R3 Anteverted Liners	11/19/2018
K201701	Smith & Nephew, Inc.	R3 HA Coated Acetabular Shells	10/06/2020
K092386	SMITH & NEPHEW, INC.	R3 MULTI-HOLE SHELLS AND 36MM XLPE ACETABULAR LINERS	11/03/2009
K102370	SMITH & NEPHEW, INC.	R3 XLPE ANTEVERTED LINERS	01/19/2011
K113848	SMITH & NEPHEW, INC.	R3 XLPE LINERS	04/27/2012
K061253	SMITH & NEPHEW, INC.	REFLECTION 3 ACETABULAR SYSTEM	05/31/2006
K070756	SMITH & NEPHEW, INC.	SMITH AND NEPHEW REFLECTION 3 ACETABULAR SYSTEM	06/06/2007
K122382	WRIGHT MEDICAL TECHNOLOGY, INC.	DYNASTY BIOFOAM SHELL	10/22/2012