FDA 510(k)

Sistema de Ombro Flexível Ascend Aequalis

Número K: K190521 · 2019-06-12

Data da decisão2019-06-12

Código do produtoKWS

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Aequalis Ascend Flex Shoulder System is the device name listed in this FDA 510(k) record. The listed applicant is Tornier S.A.S.. It received FDA 510(k) clearance on 2019-06-12 under 510(k) number K190521. The device is classified under product code KWS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Aequalis Ascend Flex Shoulder System?

Aequalis Ascend Flex Shoulder System is a medical device that received FDA 510(k) clearance on 2019-06-12. The listed applicant is Tornier S.A.S.. The 510(k) number is K190521.

When did Aequalis Ascend Flex Shoulder System receive FDA 510(k) clearance?

Aequalis Ascend Flex Shoulder System received FDA 510(k) clearance on 2019-06-12, under 510(k) number K190521.

Who is the listed applicant for Aequalis Ascend Flex Shoulder System?

The FDA 510(k) record lists Tornier S.A.S. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Aequalis Ascend Flex Shoulder System?

The FDA product code for Aequalis Ascend Flex Shoulder System is KWS.

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 Tornier S.A.S. como candidato(a)

K232265BLUEPRINT™ Patient Specific Instrumentation K222510Blueprint Mixed Reality system K203315BLUEPRINT™ Patient Specific Instrumentation K162800BLUEPRINT Patient Specific Instrumentation K161789BLUEPRINT Patient Specific Instrumentation K153452Salto XT, Salto Talaris

Ver todos os 9 dispositivos →

Dispositivos Relacionados (Código: KWS)

K260721Tornier Perform Advanced GlenoidTornier, Inc.K254084Sistema de Ombro AETOS - CONCELOC GlenoidsSmith & Nephew, Inc.K252418Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.K252416Prótese Metacôndila AETOS Shoulder System Size 0Smith & Nephew, Inc.K241292MyShoulder Planner (5.3SSWPL)Medacta International S.A.K241878Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem)Stryker Corporation (Tornier, Inc.)

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.