HEALIX ADVANCE BR ANCHOR

Fastener, Fixation, Biodegradable, Soft Tissue

DEPUY MITEK INC., JOHNSON AND JOHNSON COMPANY

The following data is part of a premarket notification filed by Depuy Mitek Inc., Johnson And Johnson Company with the FDA for Healix Advance Br Anchor.

Pre-market Notification Details

Device IDK120078
510k NumberK120078
Device Name:HEALIX ADVANCE BR ANCHOR
ClassificationFastener, Fixation, Biodegradable, Soft Tissue
Applicant DEPUY MITEK INC., JOHNSON AND JOHNSON COMPANY 325 Paramount Drive Raynham,  MA  02767
ContactYayoi Fujimaki
CorrespondentYayoi Fujimaki
DEPUY MITEK INC., JOHNSON AND JOHNSON COMPANY 325 Paramount Drive Raynham,  MA  02767
Product CodeMAI  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-01-10
Decision Date2012-02-29
Summary:summary

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