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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bone Cement
510(k) Number K172408
Device Name Biomet Bone Cement R
Applicant
Biomet, Inc.
56 E Bell Dr.
Warsaw,  IN  46581
Applicant Contact Heidi Busz
Correspondent
Biomet, Inc.
56 E Bell Dr.
Warsaw,  IN  46581
Correspondent Contact Heidi Busz
Regulation Number888.3027
Classification Product Code
LOD  
Date Received08/09/2017
Decision Date 10/05/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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