HEALIX TI ANCHOR

Screw, Fixation, Bone

DEPUY MITEK, A JOHNSON & JOHNSON CO.

The following data is part of a premarket notification filed by Depuy Mitek, A Johnson & Johnson Co. with the FDA for Healix Ti Anchor.

Pre-market Notification Details

Device IDK082282
510k NumberK082282
Device Name:HEALIX TI ANCHOR
ClassificationScrew, Fixation, Bone
Applicant DEPUY MITEK, A JOHNSON & JOHNSON CO. 325 Paramount Drive Raynham,  MA  02767
ContactKristine Christo
CorrespondentKristine Christo
DEPUY MITEK, A JOHNSON & JOHNSON CO. 325 Paramount Drive Raynham,  MA  02767
Product CodeHWC  
Subsequent Product CodeJDR
Subsequent Product CodeMBI
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-08-11
Decision Date2008-11-07
Summary:summary

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