FDA 510(k)

PRECICE Plating System

Número K: K192181 · 2019-11-07

RequerenteNuvasive Specialized Orthopedics, Inc.

Data da decisão2019-11-07

Código do produtoKTT

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

PRECICE Plating System is the device name listed in this FDA 510(k) record. The listed applicant is Nuvasive Specialized Orthopedics, Inc.. It received FDA 510(k) clearance on 2019-11-07 under 510(k) number K192181. The device is classified under product code KTT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the PRECICE Plating System?

PRECICE Plating System is a medical device that received FDA 510(k) clearance on 2019-11-07. The listed applicant is Nuvasive Specialized Orthopedics, Inc.. The 510(k) number is K192181.

When did PRECICE Plating System receive FDA 510(k) clearance?

PRECICE Plating System received FDA 510(k) clearance on 2019-11-07, under 510(k) number K192181.

Who is the listed applicant for PRECICE Plating System?

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

What is the FDA product code for PRECICE Plating System?

The FDA product code for PRECICE Plating System is KTT.

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Fonte oficial

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