FDA 510(k)

Eleganz Fusion Screw System (Fusion Screw System)

K-Number: K250251 · 2025-06-13

ApplicantDev4

Decision Date2025-06-13

Product CodeHWC

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Eleganz Fusion Screw System (Fusion Screw System) is the device name listed in this FDA 510(k) record. The listed applicant is Dev4. It received FDA 510(k) clearance on 2025-06-13 under 510(k) number K250251. 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 Eleganz Fusion Screw System (Fusion Screw System)?

Eleganz Fusion Screw System (Fusion Screw System) is a medical device that received FDA 510(k) clearance on 2025-06-13. The listed applicant is Dev4. The 510(k) number is K250251.

When did Eleganz Fusion Screw System (Fusion Screw System) receive FDA 510(k) clearance?

Eleganz Fusion Screw System (Fusion Screw System) received FDA 510(k) clearance on 2025-06-13, under 510(k) number K250251.

Who is the listed applicant for Eleganz Fusion Screw System (Fusion Screw System)?

The FDA 510(k) record lists Dev4 as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Eleganz Fusion Screw System (Fusion Screw System)?

The FDA product code for Eleganz Fusion Screw System (Fusion Screw System) is HWC. This falls under the Cardiovascular category.

Other records listing Dev4 as applicant

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.

K252312Eleganz IM Threaded Nail System (IM Threaded Nail System)

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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.