MILAGRO INTERFERENCE SCREW

Screw, Fixation, Bone

DEPUY MITEK, A JOHNSON & JOHNSON COMPANY

The following data is part of a premarket notification filed by Depuy Mitek, A Johnson & Johnson Company with the FDA for Milagro Interference Screw.

Pre-market Notification Details

Device IDK060830
510k NumberK060830
Device Name:MILAGRO INTERFERENCE SCREW
ClassificationScrew, Fixation, Bone
Applicant DEPUY MITEK, A JOHNSON & JOHNSON COMPANY 325 PARAMOUNT DR. Raynham,  MA  02767
ContactRuth Forstadt
CorrespondentRuth Forstadt
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY 325 PARAMOUNT DR. Raynham,  MA  02767
Product CodeHWC  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-03-27
Decision Date2006-06-15
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10886705010684 K060830 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.