FDA 510(k)

The Hammertoe Correction System

N.º K: K153065 · 2016-08-01

Fecha de decisión2016-08-01

Código de productoHWC

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

The Hammertoe Correction System is the device name listed in this FDA 510(k) record. The listed applicant is Life Spine, Inc.. It received FDA 510(k) clearance on 2016-08-01 under 510(k) number K153065. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the The Hammertoe Correction System?

The Hammertoe Correction System is a medical device that received FDA 510(k) clearance on 2016-08-01. The listed applicant is Life Spine, Inc.. The 510(k) number is K153065.

When did The Hammertoe Correction System receive FDA 510(k) clearance?

The Hammertoe Correction System received FDA 510(k) clearance on 2016-08-01, under 510(k) number K153065.

Who is the listed applicant for The Hammertoe Correction System?

The FDA 510(k) record lists Life Spine, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for The Hammertoe Correction System?

The FDA product code for The Hammertoe Correction System is HWC. This falls under the Cardiovascular category.

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Fuente oficial

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