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FDA 510(k)

Spineology Navigation Instruments

K-Number: K251943 · 2025-12-04

ApplicantSpineology, Inc.
Decision Date2025-12-04
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Spineology Navigation Instruments is a medical device manufactured by Spineology, Inc.. It received FDA 510(k) clearance on 2025-12-04 under approval number K251943. 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 Spineology Navigation Instruments?

Spineology Navigation Instruments is a medical device that received FDA 510(k) clearance on 2025-12-04. It is manufactured by Spineology, Inc.. The 510(k) number is K251943.

When was Spineology Navigation Instruments approved by the FDA?

Spineology Navigation Instruments received FDA 510(k) clearance on 2025-12-04, under approval number K251943.

What company makes Spineology Navigation Instruments?

Spineology Navigation Instruments is manufactured by Spineology, Inc..

What is the FDA product code for Spineology Navigation Instruments?

The FDA product code for Spineology Navigation Instruments is OLO.

Related Clinical Trials

NCT07518615 Clinical Safety and Effectiveness of the Straumann Dynamic Navigation System Falcon RECRUITING

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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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