FDA 510(k)

ONVOY™ Acetabular System

Número K: K243456 · 2025-06-06

Data da decisão2025-06-06

Código do produtoLPH

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

ONVOY™ Acetabular System 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 2025-06-06 under 510(k) number K243456. The device is classified under product code LPH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the ONVOY™ Acetabular System?

ONVOY™ Acetabular System is a medical device that received FDA 510(k) clearance on 2025-06-06. The listed applicant is Globus Medical, Inc.. The 510(k) number is K243456.

When did ONVOY™ Acetabular System receive FDA 510(k) clearance?

ONVOY™ Acetabular System received FDA 510(k) clearance on 2025-06-06, under 510(k) number K243456.

Who is the listed applicant for ONVOY™ Acetabular System?

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 ONVOY™ Acetabular System?

The FDA product code for ONVOY™ Acetabular System is LPH.

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Fonte oficial

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