ACCELL EVO3 (FORMERLY ACCELL A2I)

Filler, Bone Void, Osteoinduction (w/o Human Growth Factor)

INTEGRA LIFESCIENCES

The following data is part of a premarket notification filed by Integra Lifesciences with the FDA for Accell Evo3 (formerly Accell A2i).

Pre-market Notification Details

Device IDK103742
510k NumberK103742
Device Name:ACCELL EVO3 (FORMERLY ACCELL A2I)
ClassificationFiller, Bone Void, Osteoinduction (w/o Human Growth Factor)
Applicant INTEGRA LIFESCIENCES 2 GOODYEAR Irvine,  CA  92672
ContactJenny Fam
CorrespondentJenny Fam
INTEGRA LIFESCIENCES 2 GOODYEAR Irvine,  CA  92672
Product CodeMBP  
CFR Regulation Number888.3045 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-12-23
Decision Date2011-03-17
Summary:summary

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