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U.S. Department of Health and Human Services

510(k) Premarket Notification

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1 to 10 of 12 Results
ProductCode: HAW Applicant: ORTHOSOFT, INC. Decision Date To: 06/25/2022
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navitrack system- partial hip resurfacing universal ORTHOSOFT, INC. K071929 09/19/2007
navitrack system - os unicondylar knee universal, model# pro-06003 ORTHOSOFT, INC. K071714 07/20/2007
navitrack system-os knee universal, model pro-05002 ORTHOSOFT, INC. K060336 04/28/2006
navitrack system - s&n image free knee ORTHOSOFT, INC. K043536 01/14/2005
navitrack system - s&n image free hip, model pro-03017 ORTHOSOFT, INC. K041369 06/22/2004
navitrack system - total hip replacement ct-free ORTHOSOFT, INC. K032917 10/21/2003
navitrack system: total hip replacement ct-free cup, model 900.204 ORTHOSOFT, INC. K030827 05/23/2003
navitrack system-fluorospine, model 900.005 ORTHOSOFT, INC. K031156 05/09/2003
navitrack system total hip replacement,model 900.200 ORTHOSOFT, INC. K022364 02/04/2003
navitrack system-optical tkr ct-less, model 900.120 ORTHOSOFT, INC. K021760 08/27/2002