Cleared Traditional

CurvaFix Low Profile System

K252019 · Curvafix, Inc. · Orthopedic

Aug 2025

Decision

60d

Days

Class 2

Risk

About This 510(k) Submission

K252019 is an FDA 510(k) clearance for the CurvaFix Low Profile System, a Screw, Fixation, Bone (Class II — Special Controls, product code HWC), submitted by Curvafix, Inc. (Bellevue, US). The FDA issued a Cleared decision on August 29, 2025, 60 days after receiving the submission on June 30, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number	K252019 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 30, 2025
Decision Date	August 29, 2025
Days to Decision	60 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF