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 |