Cleared Traditional

T2 Alpha Femur Retrograde Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Tibial Nailing System, T2 Femoral System, T2 Supracondylar Nail System

K203819 · Stryker GmbH · Orthopedic

Feb 2021

Decision

59d

Days

Class 2

Risk

About This 510(k) Submission

K203819 is an FDA 510(k) clearance for the T2 Alpha Femur Retrograde Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Tibial Nailing System, T2 Femoral System, T2 Supracondylar Nail 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 February 26, 2021, 59 days after receiving the submission on December 29, 2020. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3020.

Submission Details

510(k) Number	K203819 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 29, 2020
Decision Date	February 26, 2021
Days to Decision	59 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF