FDA 510(k)

IvyAIR Meniscus System, Curved, IvyAIR Meniscus System, Straight, IvyAIR Meniscus System, Reverse Curved

N.º K: K153087 · 2016-07-14

Fecha de decisión2016-07-14

Código de productoGAT

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

IvyAIR Meniscus System, Curved, IvyAIR Meniscus System, Straight, IvyAIR Meniscus System, Reverse Curved is the device name listed in this FDA 510(k) record. The listed applicant is Ivy Sports Medicine, LLC. It received FDA 510(k) clearance on 2016-07-14 under 510(k) number K153087. The device is classified under product code GAT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the IvyAIR Meniscus System, Curved, IvyAIR Meniscus System, Straight, IvyAIR Meniscus System, Reverse Curved?

IvyAIR Meniscus System, Curved, IvyAIR Meniscus System, Straight, IvyAIR Meniscus System, Reverse Curved is a medical device that received FDA 510(k) clearance on 2016-07-14. The listed applicant is Ivy Sports Medicine, LLC. The 510(k) number is K153087.

When did IvyAIR Meniscus System, Curved, IvyAIR Meniscus System, Straight, IvyAIR Meniscus System, Reverse Curved receive FDA 510(k) clearance?

IvyAIR Meniscus System, Curved, IvyAIR Meniscus System, Straight, IvyAIR Meniscus System, Reverse Curved received FDA 510(k) clearance on 2016-07-14, under 510(k) number K153087.

Who is the listed applicant for IvyAIR Meniscus System, Curved, IvyAIR Meniscus System, Straight, IvyAIR Meniscus System, Reverse Curved?

The FDA 510(k) record lists Ivy Sports Medicine, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IvyAIR Meniscus System, Curved, IvyAIR Meniscus System, Straight, IvyAIR Meniscus System, Reverse Curved?

The FDA product code for IvyAIR Meniscus System, Curved, IvyAIR Meniscus System, Straight, IvyAIR Meniscus System, Reverse Curved is GAT.

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Otros registros que enlistan a Ivy Sports Medicine, LLC como solicitante

K170364Collagen Meniscus Implant XL

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Fuente oficial

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