FDA 510(k)

PRECICE UNYTE CoCr System

Número K: K162927 · 2017-04-06

RequerenteNuvasive Specialized Orthopedics, Inc.

Data da decisão2017-04-06

Código do produtoHSB

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

PRECICE UNYTE CoCr 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 2017-04-06 under 510(k) number K162927. 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 CoCr System?

PRECICE UNYTE CoCr System is a medical device that received FDA 510(k) clearance on 2017-04-06. The listed applicant is Nuvasive Specialized Orthopedics, Inc.. The 510(k) number is K162927.

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

PRECICE UNYTE CoCr System received FDA 510(k) clearance on 2017-04-06, under 510(k) number K162927.

Who is the listed applicant for PRECICE UNYTE CoCr 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 CoCr System?

The FDA product code for PRECICE UNYTE CoCr System is HSB.

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Fonte oficial

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