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FDA 510(k)

SPINEART Navigation Instrument System

K-Number: K210472 · 2021-03-19

ApplicantSpineart
Decision Date2021-03-19
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SPINEART Navigation Instrument System is a medical device manufactured by Spineart. It received FDA 510(k) clearance on 2021-03-19 under approval number K210472. 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 2021-03-19. It is manufactured by Spineart. The 510(k) number is K210472.

When was SPINEART Navigation Instrument System approved by the FDA?

SPINEART Navigation Instrument System received FDA 510(k) clearance on 2021-03-19, under approval number K210472.

What company makes SPINEART Navigation Instrument System?

SPINEART Navigation Instrument System is manufactured by Spineart.

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

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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)

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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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