FDA 510(k)

PRECICE Intramedullary Limb Lengthening System

Número K: K160325 · 2016-04-04

Data da decisão2016-04-04

Código do produtoHSB

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

PRECICE Intramedullary Limb Lengthening System is the device name listed in this FDA 510(k) record. The listed applicant is Ellipse Technologies, Inc.. It received FDA 510(k) clearance on 2016-04-04 under 510(k) number K160325. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the PRECICE Intramedullary Limb Lengthening System?

PRECICE Intramedullary Limb Lengthening System is a medical device that received FDA 510(k) clearance on 2016-04-04. The listed applicant is Ellipse Technologies, Inc.. The 510(k) number is K160325.

When did PRECICE Intramedullary Limb Lengthening System receive FDA 510(k) clearance?

PRECICE Intramedullary Limb Lengthening System received FDA 510(k) clearance on 2016-04-04, under 510(k) number K160325.

Who is the listed applicant for PRECICE Intramedullary Limb Lengthening System?

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

What is the FDA product code for PRECICE Intramedullary Limb Lengthening System?

The FDA product code for PRECICE Intramedullary Limb Lengthening System is HSB.

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