BIOCRYL RAPIDE INTERFERENCE SCREW

Screw, Fixation, Bone

MITEK WORLDWIDE

The following data is part of a premarket notification filed by Mitek Worldwide with the FDA for Biocryl Rapide Interference Screw.

Pre-market Notification Details

Device IDK032717
510k NumberK032717
Device Name:BIOCRYL RAPIDE INTERFERENCE SCREW
ClassificationScrew, Fixation, Bone
Applicant MITEK WORLDWIDE A JOHNSON & JOHNSON COMPANY 249 VANDERBILT AVENUE Norwood,  MA  02062
ContactKaren K Sylvia
CorrespondentKaren K Sylvia
MITEK WORLDWIDE A JOHNSON & JOHNSON COMPANY 249 VANDERBILT AVENUE Norwood,  MA  02062
Product CodeHWC  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-09-02
Decision Date2004-03-31
Summary:summary

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