FDA 510(k)

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

N.º K: K251400 · 2025-08-20

Fecha de decisión2025-08-20

Código de productoHSB

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing System is the device name listed in this FDA 510(k) record. The listed applicant is Stryker GmbH. It received FDA 510(k) clearance on 2025-08-20 under 510(k) number K251400. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing System?

T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing System is a medical device that received FDA 510(k) clearance on 2025-08-20. The listed applicant is Stryker GmbH. The 510(k) number is K251400.

When did T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing System receive FDA 510(k) clearance?

T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing System received FDA 510(k) clearance on 2025-08-20, under 510(k) number K251400.

Who is the listed applicant for T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing System?

The FDA 510(k) record lists Stryker GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing System?

The FDA product code for T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing System is HSB.

Ensayos clínicos relacionados

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Otros registros que enlistan a Stryker GmbH como solicitante

K261481Pangea Femur Reconstruction System K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction System K253202Hoffmann LRF System K250163Sistema de Clavo Retrogrado T2 Alpha Fémur K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea Tibia Plating System K233919VariAx 2 Distal Radius System

Ver todos los 53 dispositivos →

Dispositivos relacionados (Código: HSB)

K261345Pediatric Nailing Platform FemurOrthoPediatrics Corp.K261481Pangea Femur Reconstruction SystemStryker GmbH K253080Sistema de Clavo Femoral AND Medical (PFNA01); Sistema de Clavo Femoral AND Medical (PFNA02)Suzhou and Science & Technology Development Corp.K261651Precice™ Max System and Precice™ Ankle Salvage SystemNuVasive Specialized Orthopedics K253155Fule Metallic Lockable Intramedullary Nail SystemsBeijing Fule Science & Technology Development Co., Ltd.K253046HERA Interlocking Intramedullary Nailing SystemZheJiang Decans Medical Devices Co., Ltd.

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.