Actis DuoFix Hip Prosthesis- Collarless

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

DePuy Ireland UC

The following data is part of a premarket notification filed by Depuy Ireland Uc with the FDA for Actis Duofix Hip Prosthesis- Collarless.

Pre-market Notification Details

Device IDK210581
510k NumberK210581
Device Name:Actis DuoFix Hip Prosthesis- Collarless
ClassificationProsthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate
Applicant DePuy Ireland UC Loughbeg Ringaskiddy,  IE
ContactElaine Pears
CorrespondentErin Combs
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 Received2021-02-26
Decision Date2021-05-20

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