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FDA 510(k)

CROSSNAV Navigation Enabled Instruments for Disc Preparation and Interbody

K-Number: K254157 · 2026-05-26

ApplicantMedos International SARL
Decision Date2026-05-26
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

CROSSNAV Navigation Enabled Instruments for Disc Preparation and Interbody is the device name listed in this FDA 510(k) record. The listed applicant is Medos International SARL. It received FDA 510(k) clearance on 2026-05-26 under 510(k) number K254157. 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 CROSSNAV Navigation Enabled Instruments for Disc Preparation and Interbody?

CROSSNAV Navigation Enabled Instruments for Disc Preparation and Interbody is a medical device that received FDA 510(k) clearance on 2026-05-26. The listed applicant is Medos International SARL. The 510(k) number is K254157.

When did CROSSNAV Navigation Enabled Instruments for Disc Preparation and Interbody receive FDA 510(k) clearance?

CROSSNAV Navigation Enabled Instruments for Disc Preparation and Interbody received FDA 510(k) clearance on 2026-05-26, under 510(k) number K254157.

Who is the listed applicant for CROSSNAV Navigation Enabled Instruments for Disc Preparation and Interbody?

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

What is the FDA product code for CROSSNAV Navigation Enabled Instruments for Disc Preparation and Interbody?

The FDA product code for CROSSNAV Navigation Enabled Instruments for Disc Preparation and Interbody is OLO.

Related Clinical Trials

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.

NCT04289480Safety and Effectiveness of ENTERPRISE 2 Device in the Endovascular Treatment of Intracranial AneurysmsACTIVE_NOT_RECRUITINGNCT05316311A Study of Implantation of CRENEOUS ENTERPRISE 2 Intracranial Stent in Participants With Severe Symptomatic Intracranial Atherosclerotic StenosisCOMPLETED

Other records listing Medos International SARL 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.

K260240SYMPHONY Navigation Ready InstrumentsK253249TriALTIS™ Spine SystemK243249TriALTIS™ Spine SystemK241893CROSSNAV Navigation Enabled Instruments and UNAS Navigation ArraysK242042TriALTIS™ Spine SystemK233684TriALTIS™ Spine System

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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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