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FDA 510(k)

Altus Spine Navigation System

K-Number: K243419 · 2025-05-08

ApplicantAltus Partners, LLC
Decision Date2025-05-08
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Altus Spine Navigation System is a medical device manufactured by Altus Partners, LLC. It received FDA 510(k) clearance on 2025-05-08 under approval number K243419. 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 Altus Spine Navigation System?

Altus Spine Navigation System is a medical device that received FDA 510(k) clearance on 2025-05-08. It is manufactured by Altus Partners, LLC. The 510(k) number is K243419.

When was Altus Spine Navigation System approved by the FDA?

Altus Spine Navigation System received FDA 510(k) clearance on 2025-05-08, under approval number K243419.

What company makes Altus Spine Navigation System?

Altus Spine Navigation System is manufactured by Altus Partners, LLC.

What is the FDA product code for Altus Spine Navigation System?

The FDA product code for Altus 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 Altus Partners, LLC

K170553Altus Spine Interbody Fusion System K172253Altus Spine Cervical Interbody Fusion System K171329Altus Spine Titanium Interbody Fusion System K170512Altus Spine Titanium Interbody Fusion System K163061Altus Spine Cervical Plate System K160976Altus Spine Interbody Fusion System

View all 16 devices →

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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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