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FDA 510(k)

Spine Navigation System

K-Number: K233725 · 2024-07-26

ApplicantMedivis, Inc.
Decision Date2024-07-26
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Spine Navigation System is a medical device manufactured by Medivis, Inc.. It received FDA 510(k) clearance on 2024-07-26 under approval number K233725. 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 Spine Navigation System?

Spine Navigation System is a medical device that received FDA 510(k) clearance on 2024-07-26. It is manufactured by Medivis, Inc.. The 510(k) number is K233725.

When was Spine Navigation System approved by the FDA?

Spine Navigation System received FDA 510(k) clearance on 2024-07-26, under approval number K233725.

What company makes Spine Navigation System?

Spine Navigation System is manufactured by Medivis, Inc..

What is the FDA product code for Spine Navigation System?

The FDA product code for 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) PMID: 36074993 Reported Events Associated With Spine Robots: An Analysis of the Food and Drug Administration's Manufacturer and User Facility Device Experience Database. Global spine journal (2023)

Other Devices by Medivis, Inc.

K190764SurgicalAR K231897NeuroAlign software

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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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