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FDA 510(k)

NEXXT SPINE NAVIGATION System

K-Number: K220291 · 2022-03-31

ApplicantNexxt Spine, LLC
Decision Date2022-03-31
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NEXXT SPINE NAVIGATION System is a medical device manufactured by Nexxt Spine, LLC. It received FDA 510(k) clearance on 2022-03-31 under approval number K220291. 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 NEXXT SPINE NAVIGATION System?

NEXXT SPINE NAVIGATION System is a medical device that received FDA 510(k) clearance on 2022-03-31. It is manufactured by Nexxt Spine, LLC. The 510(k) number is K220291.

When was NEXXT SPINE NAVIGATION System approved by the FDA?

NEXXT SPINE NAVIGATION System received FDA 510(k) clearance on 2022-03-31, under approval number K220291.

What company makes NEXXT SPINE NAVIGATION System?

NEXXT SPINE NAVIGATION System is manufactured by Nexxt Spine, LLC.

What is the FDA product code for NEXXT SPINE NAVIGATION System?

The FDA product code for NEXXT SPINE 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)

Other Devices by Nexxt Spine, LLC

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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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