Naviswiss Hip Navigation System

Orthopedic Stereotaxic Instrument

Naviswiss AG

The following data is part of a premarket notification filed by Naviswiss Ag with the FDA for Naviswiss Hip Navigation System.

Pre-market Notification Details

Device IDK193094
510k NumberK193094
Device Name:Naviswiss Hip Navigation System
ClassificationOrthopedic Stereotaxic Instrument
Applicant Naviswiss AG Stahlrain 2 Brugg,  CH 5200
ContactJan Stifter
CorrespondentViky Verna
confinis 15807 Glacier Ct Potomac,  MD  20878
Product CodeOLO  
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-11-07
Decision Date2020-06-10

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