FDA 510(k)

PERIMETER C (Titanium) Spinal System

Número K: K153438 · 2016-03-02

RequerenteMedtronic Sofamor Danek USA, Inc.

Data da decisão2016-03-02

Código do produtoODP

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

PERIMETER C (Titanium) Spinal System is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Sofamor Danek USA, Inc.. It received FDA 510(k) clearance on 2016-03-02 under 510(k) number K153438. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the PERIMETER C (Titanium) Spinal System?

PERIMETER C (Titanium) Spinal System is a medical device that received FDA 510(k) clearance on 2016-03-02. The listed applicant is Medtronic Sofamor Danek USA, Inc.. The 510(k) number is K153438.

When did PERIMETER C (Titanium) Spinal System receive FDA 510(k) clearance?

PERIMETER C (Titanium) Spinal System received FDA 510(k) clearance on 2016-03-02, under 510(k) number K153438.

Who is the listed applicant for PERIMETER C (Titanium) Spinal System?

The FDA 510(k) record lists Medtronic Sofamor Danek USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PERIMETER C (Titanium) Spinal System?

The FDA product code for PERIMETER C (Titanium) Spinal System is ODP.

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