FDA 510(k)

ExactechGPS® Total Ankle Application

Número K: K232521 · 2023-11-16

Data da decisão2023-11-16

Código do produtoOLO

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

ExactechGPS® Total Ankle Application is the device name listed in this FDA 510(k) record. The listed applicant is Blue Ortho. It received FDA 510(k) clearance on 2023-11-16 under 510(k) number K232521. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the ExactechGPS® Total Ankle Application?

ExactechGPS® Total Ankle Application is a medical device that received FDA 510(k) clearance on 2023-11-16. The listed applicant is Blue Ortho. The 510(k) number is K232521.

When did ExactechGPS® Total Ankle Application receive FDA 510(k) clearance?

ExactechGPS® Total Ankle Application received FDA 510(k) clearance on 2023-11-16, under 510(k) number K232521.

Who is the listed applicant for ExactechGPS® Total Ankle Application?

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

What is the FDA product code for ExactechGPS® Total Ankle Application?

The FDA product code for ExactechGPS® Total Ankle Application is OLO.

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Outros registros que listam Blue Ortho como candidato(a)

K233299ExactechGPS® System K213877ExactechGPS® System K213546ExactechGPS Total Shoulder Application, Equinoxe Planning Software K193618ExactechGPS System K173372ExactechGPS Total Shoulder Application K162567ExactechGPS Total Shoulder Application, Equinoxe Planning Software

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