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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 the device name listed in this FDA 510(k) record. The listed applicant is Zimed Medikal. It received FDA 510(k) clearance on 2024-01-04 under 510(k) 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. The listed applicant is Zimed Medikal. The 510(k) number is K230507.

When did Zimed Distal Medial Tibial Plate and Screw System receive FDA 510(k) clearance?

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

Who is the listed applicant for Zimed Distal Medial Tibial Plate and Screw System?

The FDA 510(k) record lists Zimed Medikal as the applicant. This does not by itself establish the device manufacturer.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT06636136Transtibial OsseointegrationRECRUITING

Related Devices (Code: HWC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262344Large Compression ScrewsTriMed, Inc.K253858GFS - Sterile Screws and Top HatT.A.G. Medical Products Corporation, Ltd.K262075Lapidus Screw KitRelja Innovations, LLCK260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.K253108VEOFIX Snap Off ScrewSteps OrthoK261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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