FASTIN RC 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 Fastin Rc Anchor.

Pre-market Notification Details

Device IDK041075
510k NumberK041075
Device Name:FASTIN RC ANCHOR
ClassificationScrew, Fixation, Bone
Applicant DEPUY MITEK, A JOHNSON & JOHNSON COMPANY 249 VANDERBILT DR. Norwood,  MA  02062
ContactKaren Sylvia
CorrespondentKaren Sylvia
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY 249 VANDERBILT DR. Norwood,  MA  02062
Product CodeHWC  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-04-26
Decision Date2004-11-09
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10886705008728 K041075 000
10886705008711 K041075 000
10886705008704 K041075 000
10886705008698 K041075 000
10886705008292 K041075 000

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