HEALIX ADVANCE KNOTLESS 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 Healix Advance Knotless Br Anchor.

Pre-market Notification Details

Device IDK130917
510k NumberK130917
Device Name:HEALIX ADVANCE KNOTLESS BR ANCHOR
ClassificationFastener, Fixation, Biodegradable, Soft Tissue
Applicant DEPUY MITEK, A JOHNSON & JOHNSON COMPANY 325 PARAMOUNT DR. Raynham,  MA  02767
ContactYayoi Fujimaki
CorrespondentYayoi Fujimaki
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY 325 PARAMOUNT DR. Raynham,  MA  02767
Product CodeMAI  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-04-03
Decision Date2013-05-24
Summary:summary

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