Cleared Traditional

Baby Gorilla?/Gorilla? Plating System

K250952 · Paragon 28, Inc. · Orthopedic
Jul 2025
Decision
112d
Days
Class 2
Risk

About This 510(k) Submission

K250952 is an FDA 510(k) clearance for the Baby Gorilla?/Gorilla? Plating System, a Plate, Fixation, Bone (Class II — Special Controls, product code HRS), submitted by Paragon 28, Inc. (Englewood, US). The FDA issued a Cleared decision on July 18, 2025, 112 days after receiving the submission on March 28, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K250952 FDA.gov
FDA Decision Cleared SESE
Date Received March 28, 2025
Decision Date July 18, 2025
Days to Decision 112 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code HRS — Plate, Fixation, Bone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3030

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