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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthopedic Stereotaxic Instrument
510(k) Number K223351
Device Name Naviswiss Knee
Applicant
Naviswiss AG
Stahlrain 2
Brugg,  CH 5200
Applicant Contact Domenico Romeo
Correspondent
Confinis AG
Hauptstrasse 16
Düdingen,  CH 3186
Correspondent Contact Frederike Bruhschwein-Mandic
Regulation Number882.4560
Classification Product Code
OLO  
Date Received11/02/2022
Decision Date 01/31/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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