6-8MM X 30 MM INTRAFIX PEEK TAPERED SCREW 7-9MM X 30MM INTRAFIX PEEK TAPERED SCREW 8-10MM X 30 MM INTRAFIX PEEK TAPERED

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 6-8mm X 30 Mm Intrafix Peek Tapered Screw 7-9mm X 30mm Intrafix Peek Tapered Screw 8-10mm X 30 Mm Intrafix Peek Tapered.

Pre-market Notification Details

Device IDK122123
510k NumberK122123
Device Name:6-8MM X 30 MM INTRAFIX PEEK TAPERED SCREW 7-9MM X 30MM INTRAFIX PEEK TAPERED SCREW 8-10MM X 30 MM INTRAFIX PEEK TAPERED
ClassificationFastener, Fixation, Nondegradable, Soft Tissue
Applicant DEPUY MITEK INC., A JOHNSON AND JOHNSON COMPANY 325 Paramount Drive Raynham,  MA  02767
ContactJulie Vafides
CorrespondentJulie Vafides
DEPUY MITEK INC., A JOHNSON AND JOHNSON COMPANY 325 Paramount Drive Raynham,  MA  02767
Product CodeMBI  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-07-18
Decision Date2012-10-02
Summary:summary

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