SIGMA High Performance (HP) Partial Knee System

Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer

DePuy Ireland UC

The following data is part of a premarket notification filed by Depuy Ireland Uc with the FDA for Sigma High Performance (hp) Partial Knee System.

Pre-market Notification Details

Device IDK193549
510k NumberK193549
Device Name:SIGMA High Performance (HP) Partial Knee System
ClassificationProsthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer
Applicant DePuy Ireland UC Loughbeg Ringaskiddy,  IE
ContactErin Combs
CorrespondentBrad Osborne
DePuy Synthes, Inc. 700 Orthopaedic Drive Warsaw,  IN  46582
Product CodeHRY  
CFR Regulation Number888.3530 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-20
Decision Date2020-04-16

NIH GUDID Devices

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