FDA 510(k)

PERFORM Humeral System – Stem

Número K: K201315 · 2020-09-11

Data da decisão2020-09-11

Código do produtoPAO

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

PERFORM Humeral System – Stem is the device name listed in this FDA 510(k) record. The listed applicant is Tornier, Inc.. It received FDA 510(k) clearance on 2020-09-11 under 510(k) number K201315. The device is classified under product code PAO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the PERFORM Humeral System – Stem?

PERFORM Humeral System – Stem is a medical device that received FDA 510(k) clearance on 2020-09-11. The listed applicant is Tornier, Inc.. The 510(k) number is K201315.

When did PERFORM Humeral System – Stem receive FDA 510(k) clearance?

PERFORM Humeral System – Stem received FDA 510(k) clearance on 2020-09-11, under 510(k) number K201315.

Who is the listed applicant for PERFORM Humeral System – Stem?

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

What is the FDA product code for PERFORM Humeral System – Stem?

The FDA product code for PERFORM Humeral System – Stem is PAO.

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Outros registros que listam Tornier, Inc. como candidato(a)

K260721Tornier Perform Advanced Glenoid K252788Tornier Perform™ Reversed Monopost Glenoid (Perform Mono)K251686Tornier Humeral Reconstruction System Max (Tornier HRS Max)K230352Tornier Humeral Nail and Tornier Long Humeral Nail K220914Tornier Perform Humeral System – Fracture K220418Tornier Perform Humeral System – Stemless

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