Velora Acetabular System — 510(k) de la FDA K252067

Resumen del dispositivo

Velora Acetabular System is the device name listed in this FDA 510(k) record. The listed applicant is Restor3D, Inc.. It received FDA 510(k) clearance on 2025-12-05 under 510(k) number K252067. 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 Velora Acetabular System?

Velora Acetabular System is a medical device that received FDA 510(k) clearance on 2025-12-05. The listed applicant is Restor3D, Inc.. The 510(k) number is K252067.

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

Velora Acetabular System received FDA 510(k) clearance on 2025-12-05, under 510(k) number K252067.

Who is the listed applicant for Velora Acetabular System?

The FDA 510(k) record lists Restor3D, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Velora Acetabular System?

The FDA product code for Velora Acetabular System is LPH.

Ensayos clínicos relacionados

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Otros registros que enlistan a Restor3D, Inc. como solicitante

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K243768iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement System K242356TIDAL Fusion Cage System K240591restor3d Kinos Axiom Total Ankle System K201393restor3d MTP Implant K201314Restor3d Utility Wedge

Dispositivos relacionados (Código: LPH)

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

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

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