FDA 510(k)

Shoulder Innovations Total Shoulder System

Número K: K213615 · 2022-03-11

Data da decisão2022-03-11

Código do produtoPKC

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Shoulder Innovations Total Shoulder System is the device name listed in this FDA 510(k) record. The listed applicant is Shoulder Innovations, Inc.. It received FDA 510(k) clearance on 2022-03-11 under 510(k) number K213615. The device is classified under product code PKC. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Shoulder Innovations Total Shoulder System?

Shoulder Innovations Total Shoulder System is a medical device that received FDA 510(k) clearance on 2022-03-11. The listed applicant is Shoulder Innovations, Inc.. The 510(k) number is K213615.

When did Shoulder Innovations Total Shoulder System receive FDA 510(k) clearance?

Shoulder Innovations Total Shoulder System received FDA 510(k) clearance on 2022-03-11, under 510(k) number K213615.

Who is the listed applicant for Shoulder Innovations Total Shoulder System?

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

What is the FDA product code for Shoulder Innovations Total Shoulder System?

The FDA product code for Shoulder Innovations Total Shoulder System is PKC.

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 Shoulder Innovations, Inc. como candidato(a)

K262173N22 Offset Humeral Head K254128InSet Reverse Total Shoulder System K252516N22 EZ Glenosphere K252221Inset Reverse Total Shoulder System K241817InSet Total Shoulder System K210533Inset Reverse Total Shoulder System

Ver todos os 9 dispositivos →

Dispositivos Relacionados (Código: PKC)

K262955OsseoFit Stemless Shoulder SystemZimmer, Inc.K254154FX V135 EASYTECH® Shoulder SystemFX Shoulder Solutions, Inc.K252129Prótese de Humeral AETOS Shoulder System Sem CabeçaSmith & Nephew, Inc.K243248INHANCE INTACT™Depuy Ireland UC K241873OsseoFit Stemless Shoulder SystemZimmer, Inc.K240716Prótese de Humeral AETOS Shoulder System Sem CabeçaSmith & Nephew, 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.