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FDA 510(k)

Eleganz IM Threaded Nail System (IM Threaded Nail System)

K-Number: K252312 · 2025-10-10

ApplicantDev4
Decision Date2025-10-10
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Eleganz IM Threaded Nail System (IM Threaded Nail System) is a medical device manufactured by Dev4. It received FDA 510(k) clearance on 2025-10-10 under approval number K252312. 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 IM Threaded Nail System (IM Threaded Nail System)?

Eleganz IM Threaded Nail System (IM Threaded Nail System) is a medical device that received FDA 510(k) clearance on 2025-10-10. It is manufactured by Dev4. The 510(k) number is K252312.

When was Eleganz IM Threaded Nail System (IM Threaded Nail System) approved by the FDA?

Eleganz IM Threaded Nail System (IM Threaded Nail System) received FDA 510(k) clearance on 2025-10-10, under approval number K252312.

What company makes Eleganz IM Threaded Nail System (IM Threaded Nail System)?

Eleganz IM Threaded Nail System (IM Threaded Nail System) is manufactured by Dev4.

What is the FDA product code for Eleganz IM Threaded Nail System (IM Threaded Nail System)?

The FDA product code for Eleganz IM Threaded Nail System (IM Threaded Nail System) is HWC. This falls under the Cardiovascular category.

Other Devices by Dev4

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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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