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FDA 510(k) Applications Submitted by Carmen Albany
FDA 510(k) Number
Submission Date
Device Name
Applicant
K160071
01/13/2016
StageOne Disposable Cement Spacer Molds for Temporary Hemi-Shoulder Prosthesis
Biomet, Inc.
K150850
03/31/2015
Refobacin Bone Cement R
BIOMET, INC.
K131135
04/22/2013
BIOMET STAGE ONE DISPOSABLE CEMENT SPACER MOLDS FOR TEMPORARY HEMI-SHOULDER PROSTHESIS
BIOMET MANUFACTURING CORP.
K161166
04/26/2016
StageOne Select Cement Spacer Molds for Temporary Hip Replacement
BIOMET, INC.
K161273
05/05/2016
StageOne Disposable Cement Spacer Molds for Temporary Knee Prosthesis
Biomet, Inc.
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