Cleared Traditional

Phantom Metatarsal Shortening System

K223184 · Paragon 28, Inc. · Orthopedic
Dec 2022
Decision
65d
Days
Class 2
Risk

About This 510(k) Submission

K223184 is an FDA 510(k) clearance for the Phantom Metatarsal Shortening System, 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 December 16, 2022, 65 days after receiving the submission on October 12, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K223184 FDA.gov
FDA Decision Cleared SESE
Date Received October 12, 2022
Decision Date December 16, 2022
Days to Decision 65 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code HWC — Screw, Fixation, Bone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3040

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