FDA 510(k)

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

Número K: K251400 · 2025-08-20

Data da decisão2025-08-20

Código do produtoHSB

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do 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.

Perguntas frequentes

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.

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Outros registros que listam Stryker GmbH como candidato(a)

K261481Pangea Femur Reconstruction System K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction System K253202Hoffmann LRF System K250163Sistema de Nalga Retrograda T2 Alpha do Fêmur K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea Tibia Plating System K233919VariAx 2 Distal Radius System

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Dispositivos Relacionados (Código: HSB)

K261345Pediatric Nailing Platform FemurOrthoPediatrics Corp.K261481Pangea Femur Reconstruction SystemStryker GmbH K253080AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (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.

Fonte oficial

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