Cleared Traditional

T2 Alpha Femur Retrograde Nailing System

K250163 · Stryker GmbH · Orthopedic
Aug 2025
Decision
204d
Days
Class 2
Risk

About This 510(k) Submission

K250163 is an FDA 510(k) clearance for the T2 Alpha Femur Retrograde Nailing System, a Rod, Fixation, Intramedullary And Accessories (Class II — Special Controls, product code HSB), submitted by Stryker GmbH (Selzach, Solothurn, Ch, CH). The FDA issued a Cleared decision on August 13, 2025, 204 days after receiving the submission on January 21, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3020.

Submission Details

510(k) Number K250163 FDA.gov
FDA Decision Cleared SESE
Date Received January 21, 2025
Decision Date August 13, 2025
Days to Decision 204 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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