HEALIX ADVANCE KNOTLESS PEEK ANCHOR (6.5MM)

Fastener, Fixation, Nondegradable, Soft Tissue

DEPUY MITEK INC., A JOHNSON AND JOHNSON COMPANY

The following data is part of a premarket notification filed by Depuy Mitek Inc., A Johnson And Johnson Company with the FDA for Healix Advance Knotless Peek Anchor (6.5mm).

Pre-market Notification Details

Device IDK131683
510k NumberK131683
Device Name:HEALIX ADVANCE KNOTLESS PEEK ANCHOR (6.5MM)
ClassificationFastener, Fixation, Nondegradable, Soft Tissue
Applicant DEPUY MITEK INC., A JOHNSON AND JOHNSON COMPANY 325 Paramount Drive Raynham,  MA  02767
ContactKristine Christo
CorrespondentKristine Christo
DEPUY MITEK INC., A JOHNSON AND JOHNSON COMPANY 325 Paramount Drive Raynham,  MA  02767
Product CodeMBI  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-06-10
Decision Date2013-06-27
Summary:summary

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