DePuy PINNACLE Dual Mobility Liner

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

DePuy Ireland UC

The following data is part of a premarket notification filed by Depuy Ireland Uc with the FDA for Depuy Pinnacle Dual Mobility Liner.

Pre-market Notification Details

Device IDK200854
510k NumberK200854
Device Name:DePuy PINNACLE Dual Mobility Liner
ClassificationProsthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Applicant DePuy Ireland UC Loughbeg Ringaskiddy Co. Cork,  IE
ContactErin Combs
CorrespondentMelissa Cook
DePuy Orthopaedics, Inc. 700 Orthopaedic Drive Warsaw,  IN  46582
Product CodeLPH  
Subsequent Product CodeLZO
Subsequent Product CodeMEH
CFR Regulation Number888.3358 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-03-31
Decision Date2020-09-11

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.