FDA 510(k)

Renovis A200 PS Knee System as part of the Renovis A200 Knee System

Número K: K190122 · 2019-06-20

Data da decisão2019-06-20

Código do produtoJWH

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Renovis A200 PS Knee System as part of the Renovis A200 Knee 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 2019-06-20 under 510(k) number K190122. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Renovis A200 PS Knee System as part of the Renovis A200 Knee System?

Renovis A200 PS Knee System as part of the Renovis A200 Knee System is a medical device that received FDA 510(k) clearance on 2019-06-20. The listed applicant is Renovis Surgical Technologies. The 510(k) number is K190122.

When did Renovis A200 PS Knee System as part of the Renovis A200 Knee System receive FDA 510(k) clearance?

Renovis A200 PS Knee System as part of the Renovis A200 Knee System received FDA 510(k) clearance on 2019-06-20, under 510(k) number K190122.

Who is the listed applicant for Renovis A200 PS Knee System as part of the Renovis A200 Knee 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 A200 PS Knee System as part of the Renovis A200 Knee System?

The FDA product code for Renovis A200 PS Knee System as part of the Renovis A200 Knee System is JWH.

Ensaios clínicos relacionados

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

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

Outros registros que listam Renovis Surgical Technologies como candidato(a)

K182007Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) System K181655Renovis S180 Lateral Lumbar Interbody Fusion System K171543Renovis Surgical Hip Replacement System K170888Renovis S141 Lumbar Interbody Fusion System K153250Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System

Dispositivos Relacionados (Código: JWH)

K262057GMK ExtensionMedacta International SA K260063GSPE SpacerThe General Hospital Corporation, d/b/a Massachusetts K262293EVOLUTION MPX™ Total Knee SystemSuzhou Microport Orthorecon Co., Ltd.K262341b-ONE® Mobio™ Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem ExtensionsB-One Ortho, Corp.K262130ATTUNE Sistema de Quadril de RevisãoDepuy Orthopaedics, Inc.K253961SK Knee SystemJust Medical Devices (Tianjin) Co., Ltd.

Fonte oficial

Ver na base de dados da FDA →

Dados provenientes da FDA Open API. Para informações mais recentes e oficiais, consulte sempre o registro oficial.