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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 K254107
Device Name Refobacin Bone Cement R (110034355)
Applicant
Biomet France
Plateau De Lautagne
Valence,  FR 26000
Applicant Contact Vanessa Gautier
Correspondent
Biomet France
Plateau De Lautagne
Valence,  FR 26000
Correspondent Contact Vanessa Gautier
Regulation Number888.3027
Classification Product Code
LOD  
Subsequent Product Code
MBB  
Date Received12/19/2025
Decision Date 04/15/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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