Cleared Traditional

Eleganz IM Threaded Nail System (IM Threaded Nail System)

K252312 · Dev4 · Orthopedic

Oct 2025

Decision

78d

Days

Class 2

Risk

About This 510(k) Submission

K252312 is an FDA 510(k) clearance for the Eleganz IM Threaded Nail System (IM Threaded Nail System), a Screw, Fixation, Bone (Class II — Special Controls, product code HWC), submitted by Dev4 (Houston, US). The FDA issued a Cleared decision on October 10, 2025, 78 days after receiving the submission on July 24, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number	K252312 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 24, 2025
Decision Date	October 10, 2025
Days to Decision	78 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF