FDA 510(k)

Op.n(TM) Navigation

K-Number: K242914 · 2025-03-07

Decision Date2025-03-07

Product CodeOLO

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

Op.n(TM) Navigation is a medical device manufactured by Ecential Robotics. It received FDA 510(k) clearance on 2025-03-07 under approval number K242914. 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 Op.n(TM) Navigation?

Op.n(TM) Navigation is a medical device that received FDA 510(k) clearance on 2025-03-07. It is manufactured by Ecential Robotics. The 510(k) number is K242914.

When was Op.n(TM) Navigation approved by the FDA?

Op.n(TM) Navigation received FDA 510(k) clearance on 2025-03-07, under approval number K242914.

What company makes Op.n(TM) Navigation?

Op.n(TM) Navigation is manufactured by Ecential Robotics.

What is the FDA product code for Op.n(TM) Navigation?

The FDA product code for Op.n(TM) Navigation is OLO.

Other Devices by Ecential Robotics

K221028SURGIVISIO Device K220946SURGIVISIO Device K220627SURGIVISIO Device K231886SURGIVISIO Device K233228Spine Navigation and Robotic-Assistance Device

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

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