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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bone Grafting Material, Human Source
510(k) Number K113645
Device Name REGENEROSS ALLOGRAFT PLUS MINERLIZED
Applicant
BIOMET INTERPORE CROSS
181 TECHNOLOGY DRIVE
IRVINE,  CA  92618
Applicant Contact KATHLEEN OLIVARES
Correspondent
BIOMET INTERPORE CROSS
181 TECHNOLOGY DRIVE
IRVINE,  CA  92618
Correspondent Contact KATHLEEN OLIVARES
Regulation Number872.3930
Classification Product Code
NUN  
Date Received12/12/2011
Decision Date 01/20/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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