Cleared Traditional

T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing System

K251400 · Stryker GmbH · Orthopedic
Aug 2025
Decision
106d
Days
Class 2
Risk

About This 510(k) Submission

K251400 is an FDA 510(k) clearance for the T2 Alpha Humerus Nailing System; IMN Screws System; T2 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 20, 2025, 106 days after receiving the submission on May 6, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3020.

Submission Details

510(k) Number K251400 FDA.gov
FDA Decision Cleared SESE
Date Received May 06, 2025
Decision Date August 20, 2025
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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