FDA 510(k)

Sistema Aequalis PerFORM+ Ombro

Número K: K160975 · 2016-06-10

Data da decisão2016-06-10

Código do produtoKWS

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Aequalis PerFORM+ Shoulder System is the device name listed in this FDA 510(k) record. The listed applicant is Tornier, Inc.. It received FDA 510(k) clearance on 2016-06-10 under 510(k) number K160975. 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 PerFORM+ Shoulder System?

Aequalis PerFORM+ Shoulder System is a medical device that received FDA 510(k) clearance on 2016-06-10. The listed applicant is Tornier, Inc.. The 510(k) number is K160975.

When did Aequalis PerFORM+ Shoulder System receive FDA 510(k) clearance?

Aequalis PerFORM+ Shoulder System received FDA 510(k) clearance on 2016-06-10, under 510(k) number K160975.

Who is the listed applicant for Aequalis PerFORM+ Shoulder System?

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

What is the FDA product code for Aequalis PerFORM+ Shoulder System?

The FDA product code for Aequalis PerFORM+ 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, Inc. como candidato(a)

K260721Tornier Perform Advanced Glenoid K252788Tornier Perform™ Reversed Monopost Glenoid (Perform Mono)K251686Tornier Humeral Reconstruction System Max (Tornier HRS Max)K230352Tornier Humeral Nail and Tornier Long Humeral Nail K220914Tornier Perform Humeral System – Fracture K220418Tornier Perform Humeral System – Stemless

Ver todos os 19 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.