FDA 510(k)

PiezoImplant System

Número K: K211872 · 2022-10-12

Data da decisão2022-10-12

Código do produtoNRQ

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

PiezoImplant System is the device name listed in this FDA 510(k) record. The listed applicant is Rex Implants, Inc.. It received FDA 510(k) clearance on 2022-10-12 under 510(k) number K211872. The device is classified under product code NRQ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the PiezoImplant System?

PiezoImplant System is a medical device that received FDA 510(k) clearance on 2022-10-12. The listed applicant is Rex Implants, Inc.. The 510(k) number is K211872.

When did PiezoImplant System receive FDA 510(k) clearance?

PiezoImplant System received FDA 510(k) clearance on 2022-10-12, under 510(k) number K211872.

Who is the listed applicant for PiezoImplant System?

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

What is the FDA product code for PiezoImplant System?

The FDA product code for PiezoImplant System is NRQ.

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

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.