ACTIS Duofix Hip Prosthesis

Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented

DePuy Orthopaedics Inc.

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

Pre-market Notification Details

Device IDK202472
510k NumberK202472
Device Name:ACTIS Duofix Hip Prosthesis
ClassificationProsthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Applicant DePuy Orthopaedics Inc. 700 Orthopaedic Drive Warsaw,  IN  46582
ContactKaren Mahoney
CorrespondentAnn Geraghty
DePuy Ireland Loughbeg Ringaskiddy Cork,  IE P43ed82
Product CodeLPH  
Subsequent Product CodeKWL
Subsequent Product CodeKWY
Subsequent Product CodeMEH
CFR Regulation Number888.3358 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-08-28
Decision Date2020-10-21

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