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U.S. Department of Health and Human Services

510(k) Premarket Notification

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1 to 10 of 50 Results
ProductCode: JWH Applicant: Biomet, Inc Decision Date To: 05/29/2023
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stageone knee cement spacer molds Biomet, Inc. K213287 09/02/2022
biomet knee joint replacement prostheses Biomet, Inc K171054 07/28/2017
stageone disposable cement spacer molds for temporary knee prosthesis Biomet, Inc. K161273 01/25/2017
vanguard xp knee system BIOMET, INC. K153657 05/10/2016
oss/arcos im total femur rod BIOMET, INC. K152621 10/14/2015
vanguard 360 revision knee system Biomet, Inc. K143192 02/12/2015
biomet tibial trays BIOMET, INC. K142933 12/23/2014
vanguard xp femoral component(gen ii)/vanguard xp femoral trial BIOMET, INC. K141407 10/27/2014
vanguard 360 osseoti tibial sleeve augment BIOMET, INC. K140883 07/30/2014
e1 series a patellae, standard 3-peg, e1 series a patellae, thin 3-peg, e1 series patellae, asymmetrical, 3-peg BIOMET, INC. K140902 07/03/2014