Cleared Special

Baby Gorilla/Gorilla Plating System

K221465 · Paragon 28, Inc. · Orthopedic
Jun 2022
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K221465 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 June 17, 2022, 29 days after receiving the submission on May 19, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K221465 FDA.gov
FDA Decision Cleared SESE
Date Received May 19, 2022
Decision Date June 17, 2022
Days to Decision 29 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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