K251400

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

510(k) number: K251400
Device name: T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing System
Applicant: Stryker GmbH CH
Product code: HSB — Rod, Fixation, Intramedullary And Accessories
Decision date: 2025-08-20
Date received: 2025-05-06
Decision: Substantially Equivalent
Clearance type: Traditional
Advisory committee: Orthopedic

Also available from FDA: K251400.pdf

Official FDA record: K251400

Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.