FDA 510(k)

Adaptable Ortho Innovations Intramedullary Nail System

Número K: K210285 · 2021-03-18

RequerenteAdaptable Ortho Innovations, LLC

Data da decisão2021-03-18

Código do produtoHSB

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Adaptable Ortho Innovations Intramedullary Nail System is the device name listed in this FDA 510(k) record. The listed applicant is Adaptable Ortho Innovations, LLC. It received FDA 510(k) clearance on 2021-03-18 under 510(k) number K210285. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Adaptable Ortho Innovations Intramedullary Nail System?

Adaptable Ortho Innovations Intramedullary Nail System is a medical device that received FDA 510(k) clearance on 2021-03-18. The listed applicant is Adaptable Ortho Innovations, LLC. The 510(k) number is K210285.

When did Adaptable Ortho Innovations Intramedullary Nail System receive FDA 510(k) clearance?

Adaptable Ortho Innovations Intramedullary Nail System received FDA 510(k) clearance on 2021-03-18, under 510(k) number K210285.

Who is the listed applicant for Adaptable Ortho Innovations Intramedullary Nail System?

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

What is the FDA product code for Adaptable Ortho Innovations Intramedullary Nail System?

The FDA product code for Adaptable Ortho Innovations Intramedullary Nail System is HSB.

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