FDA 510(k)

T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction System

Número K: K253640 · 2026-02-03

Data da decisão2026-02-03

Código do produtoHSB

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction 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 2026-02-03 under 510(k) number K253640. 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 Femur Retrograde Nailing System; Pangea Femur Reconstruction System?

T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction System is a medical device that received FDA 510(k) clearance on 2026-02-03. The listed applicant is Stryker GmbH. The 510(k) number is K253640.

When did T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction System receive FDA 510(k) clearance?

T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction System received FDA 510(k) clearance on 2026-02-03, under 510(k) number K253640.

Who is the listed applicant for T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction 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 Femur Retrograde Nailing System; Pangea Femur Reconstruction System?

The FDA product code for T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction System is HSB.

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Outros registros que listam Stryker GmbH como candidato(a)

K261481Pangea Femur Reconstruction System K253202Hoffmann LRF System K251400T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing 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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