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FDA 510(k)

Curiteva Navigation System

K-Number: K223200 · 2023-01-06

ApplicantCuriteva, Inc.
Decision Date2023-01-06
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Curiteva Navigation System is a medical device manufactured by Curiteva, Inc.. It received FDA 510(k) clearance on 2023-01-06 under approval number K223200. 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 Curiteva Navigation System?

Curiteva Navigation System is a medical device that received FDA 510(k) clearance on 2023-01-06. It is manufactured by Curiteva, Inc.. The 510(k) number is K223200.

When was Curiteva Navigation System approved by the FDA?

Curiteva Navigation System received FDA 510(k) clearance on 2023-01-06, under approval number K223200.

What company makes Curiteva Navigation System?

Curiteva Navigation System is manufactured by Curiteva, Inc..

What is the FDA product code for Curiteva Navigation System?

The FDA product code for Curiteva Navigation 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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