FDA 510(k)

MARVEL™ Growing Rods

Número K: K213196 · 2022-12-19

Data da decisão2022-12-19

Código do produtoPGM

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

MARVEL™ Growing Rods is the device name listed in this FDA 510(k) record. The listed applicant is Globus Medical, Inc.. It received FDA 510(k) clearance on 2022-12-19 under 510(k) number K213196. The device is classified under product code PGM. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the MARVEL™ Growing Rods?

MARVEL™ Growing Rods is a medical device that received FDA 510(k) clearance on 2022-12-19. The listed applicant is Globus Medical, Inc.. The 510(k) number is K213196.

When did MARVEL™ Growing Rods receive FDA 510(k) clearance?

MARVEL™ Growing Rods received FDA 510(k) clearance on 2022-12-19, under 510(k) number K213196.

Who is the listed applicant for MARVEL™ Growing Rods?

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

What is the FDA product code for MARVEL™ Growing Rods?

The FDA product code for MARVEL™ Growing Rods is PGM.

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Fonte oficial

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