Cleared Traditional

Eleganz Fusion Screw System (Fusion Screw System)

K250251 · Dev4 · Orthopedic

Jun 2025

Decision

136d

Days

Class 2

Risk

About This 510(k) Submission

K250251 is an FDA 510(k) clearance for the Eleganz Fusion Screw System (Fusion Screw System), a Screw, Fixation, Bone (Class II — Special Controls, product code HWC), submitted by Dev4 (Houston, US). The FDA issued a Cleared decision on June 13, 2025, 136 days after receiving the submission on January 28, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number	K250251 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 28, 2025
Decision Date	June 13, 2025
Days to Decision	136 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF