SPIRALOK ANCHOR

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 Spiralok Anchor.

Pre-market Notification Details

Device IDK060271
510k NumberK060271
Device Name:SPIRALOK ANCHOR
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 Received2006-02-01
Decision Date2006-05-04
Summary:summary

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