FDA 510(k)

Sistema de Nivelación Antegrade GT/PF T2 Alpha Fémur, Sistema de Nivelación Tibia T2 Alpha, Sistema de Clavos IMN, Sistema de Instrumentos IMN

N.º K: K191271 · 2019-06-11

Fecha de decisión2019-06-11

Código de productoHSB

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia Nailing System, IMN Screws System, IMN Instruments System is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Trauma GmbH. It received FDA 510(k) clearance on 2019-06-11 under 510(k) number K191271. 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 Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia Nailing System, IMN Screws System, IMN Instruments System?

T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia Nailing System, IMN Screws System, IMN Instruments System is a medical device that received FDA 510(k) clearance on 2019-06-11. The listed applicant is Stryker Trauma GmbH. The 510(k) number is K191271.

When did T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia Nailing System, IMN Screws System, IMN Instruments System receive FDA 510(k) clearance?

T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia Nailing System, IMN Screws System, IMN Instruments System received FDA 510(k) clearance on 2019-06-11, under 510(k) number K191271.

Who is the listed applicant for T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia Nailing System, IMN Screws System, IMN Instruments System?

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

What is the FDA product code for T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia Nailing System, IMN Screws System, IMN Instruments System?

The FDA product code for T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia Nailing System, IMN Screws System, IMN Instruments System is HSB.

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Otros registros que enlistan a Stryker Trauma GmbH como solicitante

K200869Gamma3 System K193308T2 Alpha Tibia Nailing System, IMN Screws System K180436T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments System K172774T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments System K170418Stryker SonicPin System

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

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