Cleared Traditional

CurvaFix Intramedullary Rodscrew System

K180050 · Curvafix, Inc. · Orthopedic

Mar 2019

Decision

417d

Days

Class 2

Risk

About This 510(k) Submission

K180050 is an FDA 510(k) clearance for the CurvaFix Intramedullary Rodscrew 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 March 1, 2019, 417 days after receiving the submission on January 8, 2018. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number	K180050 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 08, 2018
Decision Date	March 01, 2019
Days to Decision	417 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF