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FDA 510(k)

FMX314 Surgical Platform

K-Number: K160797 · 2016-08-26

ApplicantFortimedix Surgical B.V.
Decision Date2016-08-26
Product CodeOTJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FMX314 Surgical Platform is a medical device manufactured by Fortimedix Surgical B.V.. It received FDA 510(k) clearance on 2016-08-26 under approval number K160797. The device is classified under product code OTJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FMX314 Surgical Platform?

FMX314 Surgical Platform is a medical device that received FDA 510(k) clearance on 2016-08-26. It is manufactured by Fortimedix Surgical B.V.. The 510(k) number is K160797.

When was FMX314 Surgical Platform approved by the FDA?

FMX314 Surgical Platform received FDA 510(k) clearance on 2016-08-26, under approval number K160797.

What company makes FMX314 Surgical Platform?

FMX314 Surgical Platform is manufactured by Fortimedix Surgical B.V..

What is the FDA product code for FMX314 Surgical Platform?

The FDA product code for FMX314 Surgical Platform is OTJ.

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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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