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FDA 510(k)

Medline UNITE Ancillary Foot Recon Plating System

N.º K: K234031 · 2024-01-18

SolicitanteMedline Industires, LP
Fecha de decisión2024-01-18
Código de productoHRS
Comité asesorOR
DecisiónSubstantially Equivalent

Resumen del dispositivo

Medline UNITE Ancillary Foot Recon Plating System is the device name listed in this FDA 510(k) record. The listed applicant is Medline Industires, LP. It received FDA 510(k) clearance on 2024-01-18 under 510(k) number K234031. 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 Medline UNITE Ancillary Foot Recon Plating System?

Medline UNITE Ancillary Foot Recon Plating System is a medical device that received FDA 510(k) clearance on 2024-01-18. The listed applicant is Medline Industires, LP. The 510(k) number is K234031.

When did Medline UNITE Ancillary Foot Recon Plating System receive FDA 510(k) clearance?

Medline UNITE Ancillary Foot Recon Plating System received FDA 510(k) clearance on 2024-01-18, under 510(k) number K234031.

Who is the listed applicant for Medline UNITE Ancillary Foot Recon Plating System?

The FDA 510(k) record lists Medline Industires, LP as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Medline UNITE Ancillary Foot Recon Plating System?

The FDA product code for Medline UNITE Ancillary Foot Recon Plating System is HRS.

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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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