FDA 510(k)

I.T.S. INS Proximal Femur Nail

N.º K: K233134 · 2024-02-12

Fecha de decisión2024-02-12

Código de productoHSB

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

I.T.S. INS Proximal Femur Nail is the device name listed in this FDA 510(k) record. The listed applicant is I.T.S. GmbH. It received FDA 510(k) clearance on 2024-02-12 under 510(k) number K233134. 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 I.T.S. INS Proximal Femur Nail?

I.T.S. INS Proximal Femur Nail is a medical device that received FDA 510(k) clearance on 2024-02-12. The listed applicant is I.T.S. GmbH. The 510(k) number is K233134.

When did I.T.S. INS Proximal Femur Nail receive FDA 510(k) clearance?

I.T.S. INS Proximal Femur Nail received FDA 510(k) clearance on 2024-02-12, under 510(k) number K233134.

Who is the listed applicant for I.T.S. INS Proximal Femur Nail?

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

What is the FDA product code for I.T.S. INS Proximal Femur Nail?

The FDA product code for I.T.S. INS Proximal Femur Nail is HSB.

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Otros registros que enlistan a I.T.S. GmbH como solicitante

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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Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.