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FDA 510(k)

Naviswiss Knee

K-Number: K223351 · 2023-01-31

ApplicantNaviswiss AG
Decision Date2023-01-31
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Naviswiss Knee is a medical device manufactured by Naviswiss AG. It received FDA 510(k) clearance on 2023-01-31 under approval number K223351. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Naviswiss Knee?

Naviswiss Knee is a medical device that received FDA 510(k) clearance on 2023-01-31. It is manufactured by Naviswiss AG. The 510(k) number is K223351.

When was Naviswiss Knee approved by the FDA?

Naviswiss Knee received FDA 510(k) clearance on 2023-01-31, under approval number K223351.

What company makes Naviswiss Knee?

Naviswiss Knee is manufactured by Naviswiss AG.

What is the FDA product code for Naviswiss Knee?

The FDA product code for Naviswiss Knee is OLO.

Other Devices by Naviswiss AG

K193094Naviswiss Hip Navigation System K211429NAVIPLAN - CT Planning Software for Total Hip Replacement

Related Devices (Code: OLO)

K162375Envision 3D: Image Guidance System7D Surgical, Inc. K162341Stryker OrthoMap Precision Knee systemStryker Leibinger GmbH & Co KG K162195TSolution One Cup1 Surgical SystemTHINK Surgical, Inc. K160385Precision ScrewCryptych Pty, Ltd. K153700Aesculap(R) Implant Systems (AIS) S4 Navigation InstrumentsAesculap Implant Systems, LLC K153240Styrker OrthoMap Express Knee SystemStryker Corporate

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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