FDA 510(k)

MOSS 100 Pedicle Screw System

Número K: K162232 · 2016-11-17

RequerenteBiedermann Motech GmbH & Co. KG

Data da decisão2016-11-17

Código do produtoNKB

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

MOSS 100 Pedicle Screw System is the device name listed in this FDA 510(k) record. The listed applicant is Biedermann Motech GmbH & Co. KG. It received FDA 510(k) clearance on 2016-11-17 under 510(k) number K162232. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the MOSS 100 Pedicle Screw System?

MOSS 100 Pedicle Screw System is a medical device that received FDA 510(k) clearance on 2016-11-17. The listed applicant is Biedermann Motech GmbH & Co. KG. The 510(k) number is K162232.

When did MOSS 100 Pedicle Screw System receive FDA 510(k) clearance?

MOSS 100 Pedicle Screw System received FDA 510(k) clearance on 2016-11-17, under 510(k) number K162232.

Who is the listed applicant for MOSS 100 Pedicle Screw System?

The FDA 510(k) record lists Biedermann Motech GmbH & Co. KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MOSS 100 Pedicle Screw System?

The FDA product code for MOSS 100 Pedicle Screw System is NKB.

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