FDA 510(k)

GaiaBone Bioabsorbable Bone Graft

Número K: K220337 · 2023-02-03

RequerenteCorliber (Shenzhen) Medical Device Co., Ltd.

Data da decisão2023-02-03

Código do produtoMQV

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

GaiaBone Bioabsorbable Bone Graft is the device name listed in this FDA 510(k) record. The listed applicant is Corliber (Shenzhen) Medical Device Co., Ltd.. It received FDA 510(k) clearance on 2023-02-03 under 510(k) number K220337. 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 GaiaBone Bioabsorbable Bone Graft?

GaiaBone Bioabsorbable Bone Graft is a medical device that received FDA 510(k) clearance on 2023-02-03. The listed applicant is Corliber (Shenzhen) Medical Device Co., Ltd.. The 510(k) number is K220337.

When did GaiaBone Bioabsorbable Bone Graft receive FDA 510(k) clearance?

GaiaBone Bioabsorbable Bone Graft received FDA 510(k) clearance on 2023-02-03, under 510(k) number K220337.

Who is the listed applicant for GaiaBone Bioabsorbable Bone Graft?

The FDA 510(k) record lists Corliber (Shenzhen) Medical Device Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GaiaBone Bioabsorbable Bone Graft?

The FDA product code for GaiaBone Bioabsorbable Bone Graft is MQV.

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Fonte oficial

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