FDA 510(k)

ONVOY™ Acetabular System

N.º K: K243456 · 2025-06-06

Fecha de decisión2025-06-06

Código de productoLPH

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del 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.

Preguntas frecuentes

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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Dispositivos relacionados (Código: LPH)

K261453G7® Acetabular SystemZimmer Biomet K253630Mpact 3D Metal FoamMedacta International S.A.K254043TRIVANCE™ Hip StemGlobus Medical, Inc.K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained Acetabular Insert; Trident® Crossfire® 0° Polyethylene Insert; Trident ® Crossfire ® 10° Polyethylene Insert;System 12 Crossfire® 10° Insert; Trident® 0° Constrained Acetabular Insert; Trident® Constrained Acetabular Liner;Trident® All Poly Constrained Acetabular Insert; Crossfire® Eccentric Insert 10°; Artisan® Bone Plug;UHR® Universal Head Bipolar ComponentHowmedica Osteonics Corp., Dba Stryker Orthopaedics K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi CoatingNextstep Arthopedix, LLC K251270Taperloc® Complete Hip StemBiomet, Inc.

Fuente oficial

Ver en la base de datos de la FDA →

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