DePuy 3D Additive TriFlange Acetabular Cup

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

DePuy International, Ltd

The following data is part of a premarket notification filed by Depuy International, Ltd with the FDA for Depuy 3d Additive Triflange Acetabular Cup.

Pre-market Notification Details

Device IDK201348
510k NumberK201348
Device Name:DePuy 3D Additive TriFlange Acetabular Cup
ClassificationProsthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Applicant DePuy International, Ltd St. Anthony's Road Leeds,  GB LS11 8DT
ContactErin Combs
CorrespondentReily Inman
DePuy Orthopaedics, Inc. 700 Orthopaedic Drive Warsaw,  IN  46582
Product CodeLPH  
CFR Regulation Number888.3358 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-05-21
Decision Date2022-06-16

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