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FDA 510(k)

Zimed Distal Medial Tibial Plate and Screw System

K-Number: K230507 · 2024-01-04

ApplicantZimed Medikal
Decision Date2024-01-04
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Zimed Distal Medial Tibial Plate and Screw System is a medical device manufactured by Zimed Medikal. It received FDA 510(k) clearance on 2024-01-04 under approval number K230507. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Zimed Distal Medial Tibial Plate and Screw System?

Zimed Distal Medial Tibial Plate and Screw System is a medical device that received FDA 510(k) clearance on 2024-01-04. It is manufactured by Zimed Medikal. The 510(k) number is K230507.

When was Zimed Distal Medial Tibial Plate and Screw System approved by the FDA?

Zimed Distal Medial Tibial Plate and Screw System received FDA 510(k) clearance on 2024-01-04, under approval number K230507.

What company makes Zimed Distal Medial Tibial Plate and Screw System?

Zimed Distal Medial Tibial Plate and Screw System is manufactured by Zimed Medikal.

What is the FDA product code for Zimed Distal Medial Tibial Plate and Screw System?

The FDA product code for Zimed Distal Medial Tibial Plate and Screw System is HWC. This falls under the Cardiovascular category.

Related Clinical Trials

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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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