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FDA 510(k)

Op.n(TM) Navigation

K-Number: K242914 · 2025-03-07

ApplicantEcential Robotics
Decision Date2025-03-07
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Op.n(TM) Navigation is the device name listed in this FDA 510(k) record. The listed applicant is Ecential Robotics. It received FDA 510(k) clearance on 2025-03-07 under 510(k) 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. The listed applicant is Ecential Robotics. The 510(k) number is K242914.

When did Op.n(TM) Navigation receive FDA 510(k) clearance?

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

Who is the listed applicant for Op.n(TM) Navigation?

The FDA 510(k) record lists Ecential Robotics as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Ecential Robotics as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261113Op.n™ Spine Navigation and Robotic GuidanceK233228Spine Navigation and Robotic-Assistance DeviceK231886SURGIVISIO DeviceK221028SURGIVISIO DeviceK220946SURGIVISIO DeviceK220627SURGIVISIO Device

View all 7 devices →

Related Devices (Code: OLO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261410Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration Kit))Suite 201, National Innovation CentreK261205SPINEART Navigation Instrument SystemSpineart SAK262121Ion-L Navigated InstrumentsSurGenTec, LLCK261024TMINI Miniature Robotic SystemTHINK Surgical, Inc.K261113Op.n™ Spine Navigation and Robotic GuidanceEcential RoboticsK261852OTS HipOrtoma AB

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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