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U.S. Department of Health and Human Services

510(k) Premarket Notification

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1 to 10 of 14 Results
ProductCode: MBH Applicant: HOWMEDICA OSTEONICS CORP Decision Date To: 06/04/2023
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triathlon total kneesystem Howmedica Osteonics Corp. dba Stryker Orthopaedics K201343 07/10/2020
triathlon posterior stabilized femoral component - beaded with peri-apatite, triathlon cruciate retaining femoral component - beaded with peri-apatite Howmedica Osteonics Corp. K200782 05/13/2020
triathlon total knee system-additional components Stryker Orthopaedics (aka Howmedica Osteonics Corp.) K190402 08/22/2019
triathlon tritanium central femoral cone augment, triathlon femoral distal augment Howmedica Osteonics Corp. (aka Stryker Orthopaedics) K190991 08/15/2019
triathlon® x3® uhmwpe tibial inserts and patellar components Howmedica Osteonics Corp aka Stryker Orthopaedics K172634 11/16/2017
duracon x3 cs tibial insert HOWMEDICA OSTEONICS CORP. K070883 05/11/2007
triathlon metal backed patella HOWMEDICA OSTEONICS CORP K061521 08/11/2006
scorpio knee system tibial inserts and patellar components HOWMEDICA OSTEONICS CORP K051977 10/12/2005
triathlon press-fit total knee system HOWMEDICA OSTEONICS CORP K051380 08/30/2005
duracon conversion and x-small symmetric patella with peri-apatite coating HOWMEDICA OSTEONICS CORP K043374 02/16/2005