DePuy Corail AMT Hip Prosthesis

Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented

DePuy Orthopaedics Inc.

The following data is part of a premarket notification filed by Depuy Orthopaedics Inc. with the FDA for Depuy Corail Amt Hip Prosthesis.

Pre-market Notification Details

Device IDK213839
510k NumberK213839
Device Name:DePuy Corail AMT Hip Prosthesis
ClassificationProsthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
Applicant DePuy Orthopaedics Inc. 700 Orthopaedic Drive Warsaw,  IN  46582
ContactErin Combs
CorrespondentPaul Shin
DePuy (Ireland) Loughbeg, Ringaskiddy Cork,  IE P43ed82
Product CodeLZO  
Subsequent Product CodeKWL
Subsequent Product CodeKWY
Subsequent Product CodeMEH
CFR Regulation Number888.3353 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-12-09
Decision Date2022-01-06

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