Summit DuoFix HA Coating

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

DePuy Orthopaedics, Inc.

The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Summit Duofix Ha Coating.

Pre-market Notification Details

Device IDK193398
510k NumberK193398
Device Name:Summit DuoFix HA Coating
ClassificationProsthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate
Applicant DePuy Orthopaedics, Inc. 700 Orthopaedic Drive Warsaw,  IN  46582
ContactErin Combs
CorrespondentMargaret Shaughnessy
DePuy (Ireland) Loughbeg, Ringaskiddy Cork,  IE P43ed82
Product CodeMEH  
CFR Regulation Number888.3353 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyOrthopedic
510k Review PanelOrthopedic
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-06
Decision Date2020-02-04

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