MODIFICATION TO: BIOKNOTLESS BR ANCHOR / LUPINE BR ANCHOR

Fastener, Fixation, Biodegradable, Soft Tissue

DEPUY MITEK, A JOHNSON & JOHNSON COMPANY

The following data is part of a premarket notification filed by Depuy Mitek, A Johnson & Johnson Company with the FDA for Modification To: Bioknotless Br Anchor / Lupine Br Anchor.

Pre-market Notification Details

Device IDK070925
510k NumberK070925
Device Name:MODIFICATION TO: BIOKNOTLESS BR ANCHOR / LUPINE BR ANCHOR
ClassificationFastener, Fixation, Biodegradable, Soft Tissue
Applicant DEPUY MITEK, A JOHNSON & JOHNSON COMPANY 325 PARAMOUNT DR. Raynham,  MA  02767
ContactKristine Christo
CorrespondentKristine Christo
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY 325 PARAMOUNT DR. Raynham,  MA  02767
Product CodeMAI  
Subsequent Product CodeGAM
Subsequent Product CodeGAS
Subsequent Product CodeGAT
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-04-03
Decision Date2007-05-02
Summary:summary

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