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U.S. Department of Health and Human Services

510(k) Premarket Notification

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1 to 5 of 5 Results
ProductCode: OLO Applicant: MEDTRONIC NAVIGATION, INC. Decision Date To: 03/22/2023
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navigated cd horizon solera screwdrivers, taps, iliac taps, legacy taps MEDTRONIC NAVIGATION, INC. K124004 03/22/2013
navigated capstone trials, clydesdale trials, capstone & clydesdale inserter MEDTRONIC NAVIGATION, INC. K131425 08/14/2013
stealthstation s7 / i7 / fusion navigation systems, axiem navigation system MEDTRONIC NAVIGATION, INC. K133444 07/25/2014
stealthstation s8 system platforms and stealthstation cranial software MEDTRONIC NAVIGATION, INC. K162309 03/31/2017
stealthstation s8 spine software v1.3.0 Medtronic Navigation, Inc. K201189 05/29/2020