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U.S. Department of Health and Human Services

510(k) Premarket Notification

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11 to 20 of 21 Results
ProductCode: JDI Applicant: STRYKER ORTHOPAEDICS Decision Date To: 05/10/2024
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restoration modular 115mm conical distal stem Howmedica Osteonics Corp., dba Stryker Orthopaedics K213129 12/21/2021
insignia hip stem Stryker Orthopaedics K211703 08/16/2021
restoration® modular hip system Howmedica Osteonics Corp. (aka Stryker Orthopaedics) K193233 05/27/2020
trident ii acetabular system Howmedica Osteonics Corp. aka Stryker Orthopaedics K191358 10/24/2019
exeter centralizer, exeter 2.5mm plug Stryker Orthopaedics K191414 08/28/2019
trident x3 acetabular inserts, adm and mdm x3 acetabular inserts, accolade ii hip system Howmedica Osteonics Corp aka Stryker Orthopaedics K182468 03/19/2019
exeter v40 femoral stem hip system, orthinox v40 femoral heads Stryker Orthopaedics K173499 03/19/2018
trident® ii acetabular system Howmedica Osteonics Corp. aka Stryker Orthopaedics K171768 10/02/2017
trident® ii tritanium® acetabular shells and 6.5 mm low profile hex screws Howmedica Osteonics Corp. aka Stryker Orthopaedics K161569 10/14/2016
stryker orthopaedics hip systems labeling update STRYKER ORTHOPAEDICS K153345 05/25/2016
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