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U.S. Department of Health and Human Services

510(k) Premarket Notification
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1 to 10 of 16 Results
ProductCode: MEH Applicant: STRYKER ORTHOPAEDICS Decision Date To: 04/19/2024
 
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stryker orthopaedics hip systems labeling update Howmedica Osteonics Corp. dba Stryker Orthopaedics K233498 12/21/2023
acetabular dome hole plug Howmedica Osteonics Corp., dba Stryker Orthopaedics K220376 03/09/2022
restoration® modular hip system Howmedica Osteonics Corp., dba Stryker Orthopaedics K212187 03/01/2022
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
trident x3 acetabular inserts, adm and mdm x3 acetabular inserts, accolade ii hip system Howmedica Osteonics Corp aka Stryker Orthopaedics K182468 03/19/2019
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
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