Ziehm RFD 3D Tracker

Orthopedic Stereotaxic Instrument

Medtronic Navigation

The following data is part of a premarket notification filed by Medtronic Navigation with the FDA for Ziehm Rfd 3d Tracker.

Pre-market Notification Details

Device IDK180816
510k NumberK180816
Device Name:Ziehm RFD 3D Tracker
ClassificationOrthopedic Stereotaxic Instrument
Applicant Medtronic Navigation 826 Coal Creek Circle Louisville,  CO  80027
ContactNicole Zimmerman
CorrespondentNicole Zimmerman
Medtronic Navigation 826 Coal Creek Circle Louisville,  CO  80027
Product CodeOLO  
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-03-29
Decision Date2018-07-11
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00763000114596 K180816 000

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