DePuy Actis DuoFix Hip Prosthesis

Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate

DEPUY (IRELAND)

The following data is part of a premarket notification filed by Depuy (ireland) with the FDA for Depuy Actis Duofix Hip Prosthesis.

Pre-market Notification Details

Device IDK160907
510k NumberK160907
Device Name:DePuy Actis DuoFix Hip Prosthesis
ClassificationProsthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate
Applicant DEPUY (IRELAND) LOUGHBEG RINGASKIDDY Co. Cork,  IE
ContactJaime Weeks
CorrespondentCorrene Ramy
DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw,  IN  46582
Product CodeMEH  
Subsequent Product CodeKWL
Subsequent Product CodeKWY
Subsequent Product CodeLPH
CFR Regulation Number888.3353 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-04-01
Decision Date2016-07-19
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10603295380764 K160907 000
10603295380641 K160907 000

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