FDA 510(k)

Legend Acetabular Liners

N.º K: K173951 · 2018-05-30

SolicitanteOrtho Development Corporation

Fecha de decisión2018-05-30

Código de productoLPH

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

Legend Acetabular Liners is the device name listed in this FDA 510(k) record. The listed applicant is Ortho Development Corporation. It received FDA 510(k) clearance on 2018-05-30 under 510(k) number K173951. 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 Legend Acetabular Liners?

Legend Acetabular Liners is a medical device that received FDA 510(k) clearance on 2018-05-30. The listed applicant is Ortho Development Corporation. The 510(k) number is K173951.

When did Legend Acetabular Liners receive FDA 510(k) clearance?

Legend Acetabular Liners received FDA 510(k) clearance on 2018-05-30, under 510(k) number K173951.

Who is the listed applicant for Legend Acetabular Liners?

The FDA 510(k) record lists Ortho Development Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Legend Acetabular Liners?

The FDA product code for Legend Acetabular Liners is LPH.

Ensayos clínicos relacionados

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Otros registros que enlistan a Ortho Development Corporation como solicitante

K233093Balanced Knee® System TriMax PS Plus Tibial Insert K211086The Progen™ Trochanteric Nail System K211471Balanced Knee System Uni K203023Pisces Spinal System K200281The Gecko Spinal System K182085Balanced Knee Revision System Trabecular Tibial Cone Augments

Ver todos los 13 dispositivos →

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 →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.