FDA 510(k)

MCP Bone Putty

Número K: K160446 · 2016-11-07

Data da decisão2016-11-07

Código do produtoMQV

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

MCP Bone Putty is the device name listed in this FDA 510(k) record. The listed applicant is Biostructures, LLC. It received FDA 510(k) clearance on 2016-11-07 under 510(k) number K160446. The device is classified under product code MQV. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the MCP Bone Putty?

MCP Bone Putty is a medical device that received FDA 510(k) clearance on 2016-11-07. The listed applicant is Biostructures, LLC. The 510(k) number is K160446.

When did MCP Bone Putty receive FDA 510(k) clearance?

MCP Bone Putty received FDA 510(k) clearance on 2016-11-07, under 510(k) number K160446.

Who is the listed applicant for MCP Bone Putty?

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

What is the FDA product code for MCP Bone Putty?

The FDA product code for MCP Bone Putty is MQV.

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