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510(k) K163081

Device
40-42mm BiPolar Head And 22mm Femoral Head
Applicant
SIGNATURE ORTHOPAEDICS PTY LTD.
510(k) number
K163081
Product code
KWY  
Decision
Substantially Equivalent (SESE)
Decision date
2018-01-29
Date received
2016-11-03
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
No

Applicant Contact#

Contact
Declan Brazil
Address
7 Sirius Rd. Lane Cove West AU 2066 2066

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code KWY  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K253357b-ONE® Bipolar HeadB-One Ortho, Corp.2026-04-13
K243634Maxx Libertas Bipolar Hip Head (Bipolar Hip)Maxx Orthopedics, Inc.2025-08-25
K231526CORAIL Cemented Femoral StemDepuy Ireland UC2023-12-19
K223441SpaceFlex Acetabular CupG21, S.R.L.2023-03-23
K221794Vario-Cup SystemWaldemar Link GmbH & Co. KG2022-07-20
K220492COPAL exchange G hip spacerHeraeus Medical GmbH2022-03-23
K200709Kyocera Bipolar Hip SystemKyocera Medical Technologies, Inc.2020-04-17
K192236Fitmore Hip StemZimmer GmbH2019-11-05
K191016COPAL exchange G Hip and Knee SpacersHeraeus Medical GmbH2019-11-01
K191297iNSitu Bipolar Hip SystemTheken Companies, LLC2019-09-17
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
K170072Fitmore® Hip StemZimmer GmbH2017-02-07

Legacy Summary#

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FDA Review#

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