C-Stem AMT LE Prosthesis

Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented

DePuy Ireland UC

The following data is part of a premarket notification filed by Depuy Ireland Uc with the FDA for C-stem Amt Le Prosthesis.

Pre-market Notification Details

Device IDK220216
510k NumberK220216
Device Name:C-Stem AMT LE Prosthesis
ClassificationProsthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Applicant DePuy Ireland UC Loughbeg, Ringaskiddy Cork,  IE
ContactSarah Matamisa
CorrespondentSarah Matamisa
DePuy Orthopaedics, Inc DePuy Ireland UC Loughbeg, Ringaskiddy, Co. Cork,  IE
Product CodeJDI  
CFR Regulation Number888.3350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-01-26
Decision Date2022-07-22

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