FDA.reportPublic FDA data

510(k) K223351

Device
Naviswiss Knee
Applicant
Naviswiss AG
510(k) number
K223351
Product code
OLO
Decision
Substantially Equivalent (SESE)
Decision date
2023-01-31
Date received
2022-11-02
Regulation
882.4560
Classification name
Orthopedic Stereotaxic Instrument
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Domenico Romeo
Address
Stahlrain 2 Brugg CH 5200 5200

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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