FDA 510(k)

PRECICE UNYTE System

Número K: K172061 · 2017-08-24

RequerenteNuvasive Specialized Orthopedics, Inc.

Data da decisão2017-08-24

Código do produtoHSB

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

PRECICE UNYTE 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 2017-08-24 under 510(k) number K172061. 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 UNYTE System?

PRECICE UNYTE System is a medical device that received FDA 510(k) clearance on 2017-08-24. The listed applicant is Nuvasive Specialized Orthopedics, Inc.. The 510(k) number is K172061.

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

PRECICE UNYTE System received FDA 510(k) clearance on 2017-08-24, under 510(k) number K172061.

Who is the listed applicant for PRECICE UNYTE 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 UNYTE System?

The FDA product code for PRECICE UNYTE System is HSB.

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Fonte oficial

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