FDA 510(k)

Precice® Screws

Número K: K193617 · 2020-05-08

RequerenteNuvasive Specialized Orthopedics, Inc.

Data da decisão2020-05-08

Código do produtoHSB

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Precice® Screws 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 2020-05-08 under 510(k) number K193617. 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® Screws?

Precice® Screws is a medical device that received FDA 510(k) clearance on 2020-05-08. The listed applicant is Nuvasive Specialized Orthopedics, Inc.. The 510(k) number is K193617.

When did Precice® Screws receive FDA 510(k) clearance?

Precice® Screws received FDA 510(k) clearance on 2020-05-08, under 510(k) number K193617.

Who is the listed applicant for Precice® Screws?

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® Screws?

The FDA product code for Precice® Screws is HSB.

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Fonte oficial

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