FDA 510(k)

MAGEC® Spinal Bracing and Distraction System

Número K: K161751 · 2016-09-02

RequerenteNuvasive Specialized Orthopedics, Inc.

Data da decisão2016-09-02

Código do produtoPGN

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

MAGEC® Spinal Bracing and Distraction 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 2016-09-02 under 510(k) number K161751. The device is classified under product code PGN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the MAGEC® Spinal Bracing and Distraction System?

MAGEC® Spinal Bracing and Distraction System is a medical device that received FDA 510(k) clearance on 2016-09-02. The listed applicant is Nuvasive Specialized Orthopedics, Inc.. The 510(k) number is K161751.

When did MAGEC® Spinal Bracing and Distraction System receive FDA 510(k) clearance?

MAGEC® Spinal Bracing and Distraction System received FDA 510(k) clearance on 2016-09-02, under 510(k) number K161751.

Who is the listed applicant for MAGEC® Spinal Bracing and Distraction 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 MAGEC® Spinal Bracing and Distraction System?

The FDA product code for MAGEC® Spinal Bracing and Distraction System is PGN.

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Dispositivos Relacionados (Código: PGN)

K233593MAGEC Spinal Bracing and Distraction SystemNuvasive Specialized Orthopedics, Incorporated K201543MAGEC® SystemNuvasive Specialized Orthopedics, Inc.K171791MAGEC® SystemNuvasive Specialized Orthopedics, Incorporated K160352MAGEC® Spinal Bracing and Distraction SystemNuvasive Specialized Orthopedics, Inc.

Fonte oficial

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