REGENEROSS ALLOGRAFT PLUS MINERLIZED

Bone Grafting Material, Human Source

BIOMET INTERPORE CROSS

The following data is part of a premarket notification filed by Biomet Interpore Cross with the FDA for Regeneross Allograft Plus Minerlized.

Pre-market Notification Details

Device IDK113645
510k NumberK113645
Device Name:REGENEROSS ALLOGRAFT PLUS MINERLIZED
ClassificationBone Grafting Material, Human Source
Applicant BIOMET INTERPORE CROSS 181 TECHNOLOGY DRIVE Irvine,  CA  92618
ContactKathleen Olivares
CorrespondentKathleen Olivares
BIOMET INTERPORE CROSS 181 TECHNOLOGY DRIVE Irvine,  CA  92618
Product CodeNUN  
CFR Regulation Number872.3930 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-12-12
Decision Date2012-01-20
Summary:summary

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