FDA 510(k)

CaP Spheres Pellet Pack

Número K: K203218 · 2021-05-04

Data da decisão2021-05-04

Código do produtoMQV

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

CaP Spheres Pellet Pack is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer Biomet Spine, Inc.. It received FDA 510(k) clearance on 2021-05-04 under 510(k) number K203218. 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 CaP Spheres Pellet Pack?

CaP Spheres Pellet Pack is a medical device that received FDA 510(k) clearance on 2021-05-04. The listed applicant is Zimmer Biomet Spine, Inc.. The 510(k) number is K203218.

When did CaP Spheres Pellet Pack receive FDA 510(k) clearance?

CaP Spheres Pellet Pack received FDA 510(k) clearance on 2021-05-04, under 510(k) number K203218.

Who is the listed applicant for CaP Spheres Pellet Pack?

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

What is the FDA product code for CaP Spheres Pellet Pack?

The FDA product code for CaP Spheres Pellet Pack is MQV.

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Fonte oficial

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