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FDA 510(k)

SPINEART Navigation Instrument System

K-Number: K242933 · 2025-06-18

ApplicantSpineart SA
Decision Date2025-06-18
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SPINEART Navigation Instrument System is a medical device manufactured by Spineart SA. It received FDA 510(k) clearance on 2025-06-18 under approval number K242933. 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 SPINEART Navigation Instrument System?

SPINEART Navigation Instrument System is a medical device that received FDA 510(k) clearance on 2025-06-18. It is manufactured by Spineart SA. The 510(k) number is K242933.

When was SPINEART Navigation Instrument System approved by the FDA?

SPINEART Navigation Instrument System received FDA 510(k) clearance on 2025-06-18, under approval number K242933.

What company makes SPINEART Navigation Instrument System?

SPINEART Navigation Instrument System is manufactured by Spineart SA.

What is the FDA product code for SPINEART Navigation Instrument System?

The FDA product code for SPINEART Navigation Instrument System is OLO.

Related Clinical Trials

NCT07616050 Evaluation of the Impact of Virtual Park on Training Motivation in Adult Patients NOT_YET_RECRUITING NCT05150197 Virtual Reality Visual Field Testing as an Alternative in Childhood Eye Disease RECRUITING NCT07173309 Evaluation of Eye Gaze Sharing in the Operating Room RECRUITING NCT07174479 Eye Gaze Guidance Evaluation in Phantoms COMPLETED NCT06631638 EMPHASYS Cup Positioning in THA With Non-Invasive Navigation (Velys Hip Navigation (VHN)) RECRUITING NCT07271238 Feasibility Study on the VERAFEYE Imaging and Navigation System for Guided Catheter Ablation Procedures RECRUITING

Related PubMed Literature

PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025)

Other Devices by Spineart SA

K183630SPINEART Navigation Instrument System K231069PERLA® TL Posterior Thoraco-lumbar Fixation System K230583Tryptik Ti K242589Scarlet® AL-T K241644SPINEART Navigation Instrument System K241321Juliet® Ti LL Lumbar Interbody Device

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Related Devices (Code: OLO)

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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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