Cleared Traditional

PediFlex Flexible Nail System

K201838 · OrthoPediatrics Corp. · Orthopedic
Jan 2021
Decision
211d
Days
Class 2
Risk

About This 510(k) Submission

K201838 is an FDA 510(k) clearance for the PediFlex Flexible Nail System, a Pin, Fixation, Smooth (Class II — Special Controls, product code HTY), submitted by OrthoPediatrics Corp. (Warsaw, US). The FDA issued a Cleared decision on January 29, 2021, 211 days after receiving the submission on July 2, 2020. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K201838 FDA.gov
FDA Decision Cleared SESE
Date Received July 02, 2020
Decision Date January 29, 2021
Days to Decision 211 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code HTY — Pin, Fixation, Smooth
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3040

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