FDA 510(k)

Reliance Spinal Screw System

Número K: K162066 · 2016-12-02

Data da decisão2016-12-02

Código do produtoMNH

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Reliance Spinal Screw System is the device name listed in this FDA 510(k) record. The listed applicant is Reliance Medical Systems, LLC. It received FDA 510(k) clearance on 2016-12-02 under 510(k) number K162066. The device is classified under product code MNH. It was reviewed by the OR advisory panel. Product code MNH falls under the category of ENT, which includes ear, nose, and throat diagnostic and surgical devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Reliance Spinal Screw System?

Reliance Spinal Screw System is a medical device that received FDA 510(k) clearance on 2016-12-02. The listed applicant is Reliance Medical Systems, LLC. The 510(k) number is K162066.

When did Reliance Spinal Screw System receive FDA 510(k) clearance?

Reliance Spinal Screw System received FDA 510(k) clearance on 2016-12-02, under 510(k) number K162066.

Who is the listed applicant for Reliance Spinal Screw System?

The FDA 510(k) record lists Reliance Medical Systems, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Reliance Spinal Screw System?

The FDA product code for Reliance Spinal Screw System is MNH. This falls under the ENT category.

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 Reliance Medical Systems, LLC como candidato(a)

K202266Reliance Cervical IBF System K210874Reliance Spinal Screw System K183049Reliance Lumbar IBF System K173283Reliance Lumbar IBF System K173102Reliance Cervical IBF System K172489Reliance Cervical IBF System

Ver todos os 8 dispositivos →

Dispositivos Relacionados (Código: MNH)

K162801CastleLoc Spinal Fixation SystemL&K BIOMED Co., Ltd.K162143FixxSure® X-LinkInnovasis, Inc.K161151Spinal fixation systemCanwell Medical Co., Ltd.K162189ANAX™ 5.5 Spinal SystemU&I Corporation K151362HC Spinal SystemHung Chun Bio-S Co., Ltd.K153404Zavation Spinal SystemZavation, LLC

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.