FDA 510(k)

Betta Link Knotless Implant System

Número K: K210498 · 2021-03-24

RequerenteT.A.G. Medical Products Corporation, Ltd.

Data da decisão2021-03-24

Código do produtoMBI

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Betta Link Knotless Implant System is the device name listed in this FDA 510(k) record. The listed applicant is T.A.G. Medical Products Corporation, Ltd.. It received FDA 510(k) clearance on 2021-03-24 under 510(k) number K210498. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Betta Link Knotless Implant System?

Betta Link Knotless Implant System is a medical device that received FDA 510(k) clearance on 2021-03-24. The listed applicant is T.A.G. Medical Products Corporation, Ltd.. The 510(k) number is K210498.

When did Betta Link Knotless Implant System receive FDA 510(k) clearance?

Betta Link Knotless Implant System received FDA 510(k) clearance on 2021-03-24, under 510(k) number K210498.

Who is the listed applicant for Betta Link Knotless Implant System?

The FDA 510(k) record lists T.A.G. Medical Products Corporation, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Betta Link Knotless Implant System?

The FDA product code for Betta Link Knotless Implant System is MBI.

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Fonte oficial

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