FDA 510(k)

Infinity™ OCT System, PASS OCT® Spinal System

Número K: K210449 · 2021-03-18

Data da decisão2021-03-18

Código do produtoNKG

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Infinity™ OCT System, PASS OCT® Spinal System is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic. It received FDA 510(k) clearance on 2021-03-18 under 510(k) number K210449. The device is classified under product code NKG. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Infinity™ OCT System, PASS OCT® Spinal System?

Infinity™ OCT System, PASS OCT® Spinal System is a medical device that received FDA 510(k) clearance on 2021-03-18. The listed applicant is Medtronic. The 510(k) number is K210449.

When did Infinity™ OCT System, PASS OCT® Spinal System receive FDA 510(k) clearance?

Infinity™ OCT System, PASS OCT® Spinal System received FDA 510(k) clearance on 2021-03-18, under 510(k) number K210449.

Who is the listed applicant for Infinity™ OCT System, PASS OCT® Spinal System?

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

What is the FDA product code for Infinity™ OCT System, PASS OCT® Spinal System?

The FDA product code for Infinity™ OCT System, PASS OCT® Spinal System is NKG.

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 Medtronic como candidato(a)

K253530Trexon™ Monofilament Synthetic Absorbable Suture K251744Affinity Pixie™ Filtro Arterial com Superfície Biológica Balance™; Affinity® Filtro Arterial de Sangue Pediátrico K233433Sphere-9Dx Diagnostic Catheter (AFR-00009)K240190MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOtherm XP Cardioplegia Delivery System Uncoated K223494CD Horizon Spinal System K223178SelectSite C304 Deflectable Catheter System, C315 Delivery System

Ver todos os 26 dispositivos →

Dispositivos Relacionados (Código: NKG)

K254260The VEGA Cervical Screw SystemGS Medical Co., Ltd.K253195TAURUS Posterior Occipital-Cervico-Thoracic Spinal SystemsZheJiang Decans Medical Devices Co., Ltd.K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw SystemCarboFix Orthopedics , Ltd.K254165Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG K253129Infinity™ OCT SystemMedtronic Sofamor Danek USA, 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.