FDA 510(k) Applications for Medical Device Product Code: MBB (Bone Cement, Antibiotic)

FDA 510(k) Applications for Medical Device Product Code "MBB"
(Bone Cement, Antibiotic)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K131135	BIOMET MANUFACTURING CORP.	BIOMET STAGE ONE DISPOSABLE CEMENT SPACER MOLDS FOR TEMPORARY HEMI-SHOULDER PROSTHESIS	01/22/2014
K150850	BIOMET, INC.	Refobacin Bone Cement R	07/16/2015
K160071	Biomet, Inc.	StageOne Disposable Cement Spacer Molds for Temporary Hemi-Shoulder Prosthesis	06/16/2016
K161273	Biomet, Inc.	StageOne Disposable Cement Spacer Molds for Temporary Knee Prosthesis	01/25/2017
K213287	Biomet, Inc.	StageOne Knee Cement Spacer Molds	09/02/2022
K161166	BIOMET, INC.	StageOne Select Cement Spacer Molds for Temporary Hip Replacement	09/08/2016
K222760	Biomet, Inc.	StageOneÖ Select Hip Cement Spacer Molds	12/28/2022
K221968	Biomet, Inc.	StageOneÖ Shoulder Cement Spacer Molds	09/15/2022
K053002	DEPUY ORTHOPAEDICS, INC.	DEPUY CMW 1 GENTAMICIN BONE CEMENT	11/22/2005
K061144	DEPUY ORTHOPAEDICS, INC.	DEPUY CMW 2 AND CMW 3 GENTAMICIN BONE CEMENT	06/08/2006
K081163	DEPUY ORTHOPAEDICS, INC.	SMARTSET GMV GENTAMICIN BONE CEMENT	05/14/2008
K192041	G21 S.r.l	G21 SpaceFlex Hip	10/29/2019
K190216	G21 S.R.L	SpaceFlex Knee	06/09/2019
K201960	G21 S.r.l	SpaceFlex Knee - 80mm Size	08/13/2020
K202338	G21 Srl	SpaceFlex Shoulder	02/17/2021
K063857	HOWMEDICA OSTEONICS CORP.	SIMPLEX P SPEEDSET WITH TOBRAMYCIN BONE CEMENT	02/26/2007
K240856	Osartis GmbH	Hip Spacer Molds; Knee Spacer Molds; Shoulder Spacer Molds	11/20/2024
K242216	Teknimed SAS	GENTAFIX« (1, 3, 3MV)	12/18/2024