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 a medical device manufactured by Dev4. It received FDA 510(k) clearance on 2025-06-13 under approval 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. It is manufactured by Dev4. The 510(k) number is K250251.

When was Eleganz Fusion Screw System (Fusion Screw System) approved by the FDA?

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

What company makes Eleganz Fusion Screw System (Fusion Screw System)?

Eleganz Fusion Screw System (Fusion Screw System) is manufactured by Dev4.

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.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION NCT04305925 Focal Laser Ablation of Prostate Cancer COMPLETED NCT07023393 Proprio Spine Measurement Tool WITHDRAWN NCT07485829 Zimmer Biomet-RibFix Titan RECRUITING NCT05565131 Performance Measurement and Safety Evaluation of the PYTHEAS® ODYSSEE Angular Assistance System for Intra-pedicular Screw Placement in Adult Spine Surgery COMPLETED

Other Devices by Dev4

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Related Devices (Code: HWC)

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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.