FDA 510(k)

Renovis Surgical Hip Replacement System

N.º K: K171543 · 2017-11-16

SolicitanteRenovis Surgical Technologies

Fecha de decisión2017-11-16

Código de productoOQG

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

Renovis Surgical Hip Replacement System is the device name listed in this FDA 510(k) record. The listed applicant is Renovis Surgical Technologies. It received FDA 510(k) clearance on 2017-11-16 under 510(k) number K171543. The device is classified under product code OQG. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Renovis Surgical Hip Replacement System?

Renovis Surgical Hip Replacement System is a medical device that received FDA 510(k) clearance on 2017-11-16. The listed applicant is Renovis Surgical Technologies. The 510(k) number is K171543.

When did Renovis Surgical Hip Replacement System receive FDA 510(k) clearance?

Renovis Surgical Hip Replacement System received FDA 510(k) clearance on 2017-11-16, under 510(k) number K171543.

Who is the listed applicant for Renovis Surgical Hip Replacement System?

The FDA 510(k) record lists Renovis Surgical Technologies as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Renovis Surgical Hip Replacement System?

The FDA product code for Renovis Surgical Hip Replacement System is OQG.

Ensayos clínicos relacionados

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Otros registros que enlistan a Renovis Surgical Technologies como solicitante

K190122Renovis A200 PS Knee System as part of the Renovis A200 Knee System K182007Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) System K181655Renovis S180 Lateral Lumbar Interbody Fusion System K170888Renovis S141 Lumbar Interbody Fusion System K153250Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System

Dispositivos relacionados (Código: OQG)

K202705Prime and DYNASTY® Additive Manufacturing ShellsMicroport Orthopedics, Inc.K203472KMTI Hip Replacement SystemKyocera Medical Technologies, Inc.K201660KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup SystemKyocera Medical Technologies, Inc.K200328Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup SystemKyocera Medical Technologies, Inc.K172651FMP Extended LinersEncore Medical L.P.K173104Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile Acetabular Insert with E-Link® PolyTotal Joint Orthopedics, Inc.

Fuente oficial

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