DePuy Corail AMT Hip Prosthesis

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

DePuy (Ireland)

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

Pre-market Notification Details

Device IDK190344
510k NumberK190344
Device Name:DePuy Corail AMT Hip Prosthesis
ClassificationProsthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
Applicant DePuy (Ireland) Loughbeg Ringaskiddy Co. Cork,  IE
ContactKathy Harris
CorrespondentMelissa Cook
DePuy Orthopaedics, Inc. 700 Orthopaedic Drive Warsaw,  IN  46582
Product CodeLZO  
Subsequent Product CodeKWL
Subsequent Product CodeKWY
Subsequent Product CodeMEH
CFR Regulation Number888.3353 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-02-14
Decision Date2019-11-01

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10603295478713 K190344 000
10603295478706 K190344 000
10603295478690 K190344 000
10603295478683 K190344 000
10603295478652 K190344 000
10603295478645 K190344 000
10603295478638 K190344 000
10603295478621 K190344 000

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