EUROPA Navigated Instruments
K-Number: K230369 · 2023-06-23
ApplicantMiRus, LLC
Decision Date2023-06-23
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
EUROPA Navigated Instruments is a medical device manufactured by MiRus, LLC. It received FDA 510(k) clearance on 2023-06-23 under approval number K230369. 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 EUROPA Navigated Instruments?
EUROPA Navigated Instruments is a medical device that received FDA 510(k) clearance on 2023-06-23. It is manufactured by MiRus, LLC. The 510(k) number is K230369.
When was EUROPA Navigated Instruments approved by the FDA?
EUROPA Navigated Instruments received FDA 510(k) clearance on 2023-06-23, under approval number K230369.
What company makes EUROPA Navigated Instruments?
EUROPA Navigated Instruments is manufactured by MiRus, LLC.
What is the FDA product code for EUROPA Navigated Instruments?
The FDA product code for EUROPA Navigated Instruments is OLO.
Other Devices by MiRus, LLC
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.