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FDA 510(k)

OrthoNext Platform System

K-Number: K242270 · 2024-12-19

ApplicantOrthofix Srl
Decision Date2024-12-19
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

OrthoNext Platform System is a medical device manufactured by Orthofix Srl. It received FDA 510(k) clearance on 2024-12-19 under approval number K242270. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OrthoNext Platform System?

OrthoNext Platform System is a medical device that received FDA 510(k) clearance on 2024-12-19. It is manufactured by Orthofix Srl. The 510(k) number is K242270.

When was OrthoNext Platform System approved by the FDA?

OrthoNext Platform System received FDA 510(k) clearance on 2024-12-19, under approval number K242270.

What company makes OrthoNext Platform System?

OrthoNext Platform System is manufactured by Orthofix Srl.

What is the FDA product code for OrthoNext Platform System?

The FDA product code for OrthoNext Platform System is QIH.

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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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