Cleared Traditional

K252600 - Pediatric Plating Platform I Small-Mini
(FDA 510(k) Clearance)

K252600 · OrthoPediatrics Corp. · Orthopedic

Oct 2025

Decision

52d

Days

Class 2

Risk

K252600 is an FDA 510(k) clearance for the Pediatric Plating Platform I Small-Mini. This device is classified as a Plate, Fixation, Bone (Class II — Special Controls, product code HRS).

Submitted by OrthoPediatrics Corp. (Warsaw, US). The FDA issued a Cleared decision on October 9, 2025, 52 days after receiving the submission on August 18, 2025.

This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number	K252600 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 18, 2025
Decision Date	October 09, 2025
Days to Decision	52 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF