FDA 510(k)

MONDRIAN Anterior Lumbar Plate System

K-Number: K231715 · 2024-01-26

Decision Date2024-01-26

Product CodeKWQ

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

MONDRIAN Anterior Lumbar Plate System is a medical device manufactured by Ctl Medical Corporation. It received FDA 510(k) clearance on 2024-01-26 under approval number K231715. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MONDRIAN Anterior Lumbar Plate System?

MONDRIAN Anterior Lumbar Plate System is a medical device that received FDA 510(k) clearance on 2024-01-26. It is manufactured by Ctl Medical Corporation. The 510(k) number is K231715.

When was MONDRIAN Anterior Lumbar Plate System approved by the FDA?

MONDRIAN Anterior Lumbar Plate System received FDA 510(k) clearance on 2024-01-26, under approval number K231715.

What company makes MONDRIAN Anterior Lumbar Plate System?

MONDRIAN Anterior Lumbar Plate System is manufactured by Ctl Medical Corporation.

What is the FDA product code for MONDRIAN Anterior Lumbar Plate System?

The FDA product code for MONDRIAN Anterior Lumbar Plate System is KWQ.

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Related Devices (Code: KWQ)

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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.