FDA 510(k)

Reliance Spinal Screw System

Número K: K210874 · 2021-05-13

Data da decisão2021-05-13

Código do produtoNKB

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 2021-05-13 under 510(k) number K210874. The device is classified under product code NKB. It was reviewed by the OR advisory panel. 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 2021-05-13. The listed applicant is Reliance Medical Systems, LLC. The 510(k) number is K210874.

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

Reliance Spinal Screw System received FDA 510(k) clearance on 2021-05-13, under 510(k) number K210874.

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 NKB.

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 K183049Reliance Lumbar IBF System K173283Reliance Lumbar IBF System K173102Reliance Cervical IBF System K172489Reliance Cervical IBF System K162066Reliance Spinal Screw System

Ver todos os 8 dispositivos →

Dispositivos Relacionados (Código: NKB)

K252139Kentrospine Viktr-MIS® Pedicle screw systemRivarp Medical Pvt., Ltd.K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.K262091FRAXION Spinal Fixation SystemOrtler Global Tibbi Gerecler Anonim Sirketi K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor Sacroiliac Fixation System with NanoACTIV Surface TechnologyXenix Medical K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O K260362QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration)MANTIZ Co., Ltd.

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.