Cleared Special

Baby Gorilla/Gorilla Plating System; Monster Screw System

K241262 · Paragon 28, Inc. · Orthopedic
Jun 2024
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K241262 is an FDA 510(k) clearance for the Baby Gorilla/Gorilla Plating System; Monster Screw 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 June 5, 2024, 30 days after receiving the submission on May 6, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K241262 FDA.gov
FDA Decision Cleared SESE
Date Received May 06, 2024
Decision Date June 05, 2024
Days to Decision 30 days
Submission Type Special
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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