FDA 510(k)

Klassic HD Hip System

N.º K: K161073 · 2016-10-19

Fecha de decisión2016-10-19

Código de productoLPH

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

Klassic HD Hip System is the device name listed in this FDA 510(k) record. The listed applicant is Total Joint Othopedics, Inc.. It received FDA 510(k) clearance on 2016-10-19 under 510(k) number K161073. 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 Klassic HD Hip System?

Klassic HD Hip System is a medical device that received FDA 510(k) clearance on 2016-10-19. The listed applicant is Total Joint Othopedics, Inc.. The 510(k) number is K161073.

When did Klassic HD Hip System receive FDA 510(k) clearance?

Klassic HD Hip System received FDA 510(k) clearance on 2016-10-19, under 510(k) number K161073.

Who is the listed applicant for Klassic HD Hip System?

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

What is the FDA product code for Klassic HD Hip System?

The FDA product code for Klassic HD Hip System 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 Total Joint Othopedics, Inc. como solicitante

K243991Klassic Knee System - Revision Tibial Baseplate K232414Klassic® Tibial Insert, PS-Post, Klassic All Poly Tibia, PS-Post K230537Klassic Knee Revision System K213580Manga Adaptadora para Cabeza Femoral BIOLOX® OPTION, +10.5mm longitud de cabeza K191399BIOLOX CONTOURA Ceramic Femoral Head K171962Klassic HD® Hip System

Ver todos los 7 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.