FDA 510(k)

FORZA PTC Spacer System

Número K: K152475 · 2016-01-14

Data da decisão2016-01-14

Código do produtoMAX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

FORZA PTC Spacer System is the device name listed in this FDA 510(k) record. The listed applicant is Orthofix, Inc.. It received FDA 510(k) clearance on 2016-01-14 under 510(k) number K152475. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the FORZA PTC Spacer System?

FORZA PTC Spacer System is a medical device that received FDA 510(k) clearance on 2016-01-14. The listed applicant is Orthofix, Inc.. The 510(k) number is K152475.

When did FORZA PTC Spacer System receive FDA 510(k) clearance?

FORZA PTC Spacer System received FDA 510(k) clearance on 2016-01-14, under 510(k) number K152475.

Who is the listed applicant for FORZA PTC Spacer System?

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

What is the FDA product code for FORZA PTC Spacer System?

The FDA product code for FORZA PTC Spacer System is MAX.

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