FDA 510(k)

coflex-IF

Número K: K153302 · 2016-09-08

Data da decisão2016-09-08

Código do produtoPEK

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

coflex-IF is the device name listed in this FDA 510(k) record. The listed applicant is Paradigm Spine, LLC. It received FDA 510(k) clearance on 2016-09-08 under 510(k) number K153302. The device is classified under product code PEK. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the coflex-IF?

coflex-IF is a medical device that received FDA 510(k) clearance on 2016-09-08. The listed applicant is Paradigm Spine, LLC. The 510(k) number is K153302.

When did coflex-IF receive FDA 510(k) clearance?

coflex-IF received FDA 510(k) clearance on 2016-09-08, under 510(k) number K153302.

Who is the listed applicant for coflex-IF?

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

What is the FDA product code for coflex-IF?

The FDA product code for coflex-IF is PEK.

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

Dispositivos Relacionados (Código: PEK)

K253250Minuteman® G6 MIS Fusion PlateSpinal Simplicity, LLC K234051Minuteman G5 MIS Fusion Plate; Minuteman G1(Posterior Fusion Plate /HA Posterior Fusion Plate); HA Minuteman G3-R MIS Fusion Plate; Minuteman G3/HA Minuteman G3Spinal Simplicity, LLC K233527Minuteman G5 MIS Fusion Plate; Minuteman G1 (Posterior Fusion Plate /HA Posterior Fusion Plate); HA Minuteman G3-R MIS Fusion Plate; Minuteman G3/HA Minuteman G3 MIS Fusion PlateSpinal Simplicity, LLC K232484KeyLift™ Expandable Interlaminar Stabilization SystemFlospine K231807primaLOK™ SP Interspinous Fusion SystemWenzel Spine, Inc.K223790Huvex Interspinous Fusion SystemDio Medical Corp.

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.