FDA 510(k)

GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System

Número K: K210534 · 2021-03-26

RequerenteGramercy Extremity Orthopedics, LLC

Data da decisão2021-03-26

Código do produtoHRS

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System is the device name listed in this FDA 510(k) record. The listed applicant is Gramercy Extremity Orthopedics, LLC. It received FDA 510(k) clearance on 2021-03-26 under 510(k) number K210534. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System?

GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System is a medical device that received FDA 510(k) clearance on 2021-03-26. The listed applicant is Gramercy Extremity Orthopedics, LLC. The 510(k) number is K210534.

When did GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System receive FDA 510(k) clearance?

GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System received FDA 510(k) clearance on 2021-03-26, under 510(k) number K210534.

Who is the listed applicant for GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System?

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

What is the FDA product code for GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System?

The FDA product code for GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System is HRS.

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Outros registros que listam Gramercy Extremity Orthopedics, LLC como candidato(a)

K212334GEO Extremity and Ankle Plating System K202817GEO Bone Screw System K200108GEO 1st MTP Joint Arthrodesis Plating System K182212Geo Staple System

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Fonte oficial

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