Cleared Traditional

CurvaFix IM System

K222505 · Curvafix, Inc. · Orthopedic

Oct 2022

Decision

70d

Days

Class 2

Risk

About This 510(k) Submission

K222505 is an FDA 510(k) clearance for the CurvaFix IM 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 October 27, 2022, 70 days after receiving the submission on August 18, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number	K222505 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 18, 2022
Decision Date	October 27, 2022
Days to Decision	70 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF