Cleared Traditional

Gamma4 System

K222309 · Stryker GmbH · Orthopedic
Nov 2022
Decision
106d
Days
Class 2
Risk

About This 510(k) Submission

K222309 is an FDA 510(k) clearance for the Gamma4 System, a Rod, Fixation, Intramedullary And Accessories (Class II — Special Controls, product code HSB), submitted by Stryker GmbH (Malwah, US). The FDA issued a Cleared decision on November 15, 2022, 106 days after receiving the submission on August 1, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3020.

Submission Details

510(k) Number K222309 FDA.gov
FDA Decision Cleared SESE
Date Received August 01, 2022
Decision Date November 15, 2022
Days to Decision 106 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code HSB — Rod, Fixation, Intramedullary And Accessories
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3020

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