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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 the device name listed in this FDA 510(k) record. The listed applicant is Dev4. It received FDA 510(k) clearance on 2025-10-10 under 510(k) 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. The listed applicant is Dev4. The 510(k) number is K252312.

When did Eleganz IM Threaded Nail System (IM Threaded Nail System) receive FDA 510(k) clearance?

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

Who is the listed applicant for Eleganz IM Threaded Nail System (IM Threaded Nail 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 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 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.

K250251Eleganz Fusion Screw System (Fusion Screw System)

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

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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