Cleared Special

Baby Gorilla?/Gorilla? Plating System

K222194 · Paragon 28, Inc. · Orthopedic
Aug 2022
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K222194 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 August 19, 2022, 28 days after receiving the submission on July 22, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K222194 FDA.gov
FDA Decision Cleared SESE
Date Received July 22, 2022
Decision Date August 19, 2022
Days to Decision 28 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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