Cleared Traditional

MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation Devices

K231231 · Paragon 28, Inc. · Orthopedic

Oct 2023

Decision

167d

Days

Class 2

Risk

About This 510(k) Submission

K231231 is an FDA 510(k) clearance for the MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation Devices, a Screw, Fixation, Bone (Class II — Special Controls, product code HWC), submitted by Paragon 28, Inc. (Englewood, US). The FDA issued a Cleared decision on October 12, 2023, 167 days after receiving the submission on April 28, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number	K231231 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 28, 2023
Decision Date	October 12, 2023
Days to Decision	167 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF