Cleared Traditional

Gamma4 System

K230512 · Stryker GmbH · Orthopedic
Jun 2023
Decision
105d
Days
Class 2
Risk

About This 510(k) Submission

K230512 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 June 9, 2023, 105 days after receiving the submission on February 24, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3020.

Submission Details

510(k) Number K230512 FDA.gov
FDA Decision Cleared SESE
Date Received February 24, 2023
Decision Date June 09, 2023
Days to Decision 105 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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