FDA 510(k)

PRECICE® BONE TRANSPORT™ System

Número K: K182170 · 2019-02-05

RequerenteNuvasive Specialized Orthopedics, Inc.

Data da decisão2019-02-05

Código do produtoHSB

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

PRECICE® BONE TRANSPORT™ 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 2019-02-05 under 510(k) number K182170. 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® BONE TRANSPORT™ System?

PRECICE® BONE TRANSPORT™ System is a medical device that received FDA 510(k) clearance on 2019-02-05. The listed applicant is Nuvasive Specialized Orthopedics, Inc.. The 510(k) number is K182170.

When did PRECICE® BONE TRANSPORT™ System receive FDA 510(k) clearance?

PRECICE® BONE TRANSPORT™ System received FDA 510(k) clearance on 2019-02-05, under 510(k) number K182170.

Who is the listed applicant for PRECICE® BONE TRANSPORT™ 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® BONE TRANSPORT™ System?

The FDA product code for PRECICE® BONE TRANSPORT™ System is HSB.

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Fonte oficial

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