FDA 510(k)

Laminectomy Rongeurs, Kerrison Rongeurs, IVD Rongeurs

Número K: K150468 · 2016-02-29

Data da decisão2016-02-29

Código do produtoHAE

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Laminectomy Rongeurs, Kerrison Rongeurs, IVD Rongeurs is the device name listed in this FDA 510(k) record. The listed applicant is K2 Medical GmbH & Co. KG. It received FDA 510(k) clearance on 2016-02-29 under 510(k) number K150468. The device is classified under product code HAE. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Laminectomy Rongeurs, Kerrison Rongeurs, IVD Rongeurs?

Laminectomy Rongeurs, Kerrison Rongeurs, IVD Rongeurs is a medical device that received FDA 510(k) clearance on 2016-02-29. The listed applicant is K2 Medical GmbH & Co. KG. The 510(k) number is K150468.

When did Laminectomy Rongeurs, Kerrison Rongeurs, IVD Rongeurs receive FDA 510(k) clearance?

Laminectomy Rongeurs, Kerrison Rongeurs, IVD Rongeurs received FDA 510(k) clearance on 2016-02-29, under 510(k) number K150468.

Who is the listed applicant for Laminectomy Rongeurs, Kerrison Rongeurs, IVD Rongeurs?

The FDA 510(k) record lists K2 Medical GmbH & Co. KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Laminectomy Rongeurs, Kerrison Rongeurs, IVD Rongeurs?

The FDA product code for Laminectomy Rongeurs, Kerrison Rongeurs, IVD Rongeurs is HAE.

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