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FDA 510(k)

Able Medical Devices Valkyrie Thoracic Fixation System

N.º K: K202889 · 2021-03-02

SolicitanteJm Longyear Manufacturing, LLC D.B.A. Able Medical Devices
Fecha de decisión2021-03-02
Código de productoHRS
Comité asesorOR
DecisiónSubstantially Equivalent

Resumen del dispositivo

Able Medical Devices Valkyrie Thoracic Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Jm Longyear Manufacturing, LLC D.B.A. Able Medical Devices. It received FDA 510(k) clearance on 2021-03-02 under 510(k) number K202889. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Able Medical Devices Valkyrie Thoracic Fixation System?

Able Medical Devices Valkyrie Thoracic Fixation System is a medical device that received FDA 510(k) clearance on 2021-03-02. The listed applicant is Jm Longyear Manufacturing, LLC D.B.A. Able Medical Devices. The 510(k) number is K202889.

When did Able Medical Devices Valkyrie Thoracic Fixation System receive FDA 510(k) clearance?

Able Medical Devices Valkyrie Thoracic Fixation System received FDA 510(k) clearance on 2021-03-02, under 510(k) number K202889.

Who is the listed applicant for Able Medical Devices Valkyrie Thoracic Fixation System?

The FDA 510(k) record lists Jm Longyear Manufacturing, LLC D.B.A. Able Medical Devices as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Able Medical Devices Valkyrie Thoracic Fixation System?

The FDA product code for Able Medical Devices Valkyrie Thoracic Fixation System is HRS.

Ensayos clínicos relacionados

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Otros registros que enlistan a Jm Longyear Manufacturing, LLC D.B.A. Able Medical Devices como solicitante

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.

K232515Valkyrie Thoracic Fixation SystemK211695Valkyrie Thoracic Fixation System

Dispositivos relacionados (Código: HRS)

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.

K261892ProRib Fixation SystemCosta Surgical, Inc.K262098EnHAnce PEEK Bunion SystemNvision Biomedical TechnologiesK262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.K261647Tempo Plating System; Ultra Compression Screw SystemPace SurgicalK261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See Catalog);FRAXION Mini Plate System (Various - See Catalog);FRAXION Bone Screw System (Various - See Catalog)Ortler Global Tibbi Gerecler Anonim SirketiK262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.

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.

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