FDA.report

510(k) K231526

Device
CORAIL Cemented Femoral Stem
Applicant
Depuy Ireland UC
510(k) number
K231526
Product code
KWY
Decision
Substantially Equivalent (SESE)
Decision date
2023-12-19
Date received
2023-05-26
Regulation
888.3390
Classification name
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Amy Joyce
Address
Loughbeg Ringaskiddy Co. Cork IE

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

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K200709Kyocera Bipolar Hip SystemKyocera Medical Technologies, Inc.2020-04-17
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K191016COPAL exchange G Hip and Knee SpacersHeraeus Medical GmbH2019-11-01
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K191569Implantcast ic-Bipolar Head SystemImplantcast GmbH2019-08-28
K183114Corin BiPolar-iCorin U.S.A. Limited2019-06-05
K173455SurgTech Bipolar Head SystemSurgtech, Inc.2018-06-14
K180130ELEOS™ Bipolar Acetabular SystemOnkos Surgical, Inc.2018-02-23
K16308140-42mm BiPolar Head and 22mm Femoral HeadSignature Orthopaedics Pty, Ltd.2018-01-29
K170072Fitmore® Hip StemZimmer GmbH2017-02-07