Cleared Special

Pediatric Nailing Platform Tibia Pediatric Nailing Platform Femur

K250623 · OrthoPediatrics Corp. · Orthopedic
Apr 2025
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K250623 is an FDA 510(k) clearance for the Pediatric Nailing Platform Tibia Pediatric Nailing Platform Femur, a Rod, Fixation, Intramedullary And Accessories (Class II — Special Controls, product code HSB), submitted by OrthoPediatrics Corp. (Warsaw, US). The FDA issued a Cleared decision on April 1, 2025, 29 days after receiving the submission on March 3, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3020.

Submission Details

510(k) Number K250623 FDA.gov
FDA Decision Cleared SESE
Date Received March 03, 2025
Decision Date April 01, 2025
Days to Decision 29 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code HSB — Rod, Fixation, Intramedullary And Accessories
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3020

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