FDA 510(k)

Smith & Nephew, Inc. R3™ Constrained Liner

Número K: K162641 · 2017-06-19

Data da decisão2017-06-19

Código do produtoKWZ

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Smith & Nephew, Inc. R3™ Constrained Liner is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew, Inc.. It received FDA 510(k) clearance on 2017-06-19 under 510(k) number K162641. The device is classified under product code KWZ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Smith & Nephew, Inc. R3™ Constrained Liner?

Smith & Nephew, Inc. R3™ Constrained Liner is a medical device that received FDA 510(k) clearance on 2017-06-19. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K162641.

When did Smith & Nephew, Inc. R3™ Constrained Liner receive FDA 510(k) clearance?

Smith & Nephew, Inc. R3™ Constrained Liner received FDA 510(k) clearance on 2017-06-19, under 510(k) number K162641.

Who is the listed applicant for Smith & Nephew, Inc. R3™ Constrained Liner?

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

What is the FDA product code for Smith & Nephew, Inc. R3™ Constrained Liner?

The FDA product code for Smith & Nephew, Inc. R3™ Constrained Liner is KWZ.

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 Smith & Nephew, Inc. como candidato(a)

K261462LANDMARK Total Knee System K261968Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981); Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one blue knotless and one black MINITAPE suture (72205982)K254084Sistema de Ombro AETOS - CONCELOC Glenoids K252416Prótese Metacôndila AETOS Shoulder System Size 0 K252129Prótese de Humeral AETOS Shoulder System Sem Cabeça K251627BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid blue); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid black); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (white); BIORAPTOR CURVED 2.3 PK Suture Anchor w/ ONE 38 ULTRABRAID (#2) Suture (cobraid black); BIORAPTOR CURVED 2.3 PK Suture Anchor w/ ONE 38 ULTRABRAID (#2) Suture (cobraid blue)

Ver todos os 112 dispositivos →

Dispositivos Relacionados (Código: KWZ)

K241461Mpact Constrained LinerMedacta International S.A.K240639PINNACLETM Constrained Acetabular LinersDepuy Ireland UC K163497EXPRT™ Revision Hip System - EXPRT™ Hip Distal Stem, EXPRT™ Hip Standard Offset Proximal Body Implant, EXPRT™ Hip Lateral Offset Proximal Body Implant, EXPRT™ Hip Capture BoltEncore Medical L.P.K161610EXPRT Revision Hip SystemEncore Medical L.P.

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.