Cleared Traditional

RONAVIS ? FX (FX-001)

K250315 · AIRS, Inc. · Orthopedic

Aug 2025

Decision

178d

Days

Class 2

Risk

About This 510(k) Submission

K250315 is an FDA 510(k) clearance for the RONAVIS ? FX (FX-001), a Pin, Fixation, Smooth (Class II — Special Controls, product code HTY), submitted by AIRS, Inc. (Daegu, KR). The FDA issued a Cleared decision on August 1, 2025, 178 days after receiving the submission on February 4, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number	K250315 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 04, 2025
Decision Date	August 01, 2025
Days to Decision	178 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF