FDA 510(k)

MEDICON Spinal Spreading Systems

Número K: K161680 · 2017-03-24

Data da decisão2017-03-24

Código do produtoGZT

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

MEDICON Spinal Spreading Systems is the device name listed in this FDA 510(k) record. The listed applicant is Medicon EG. It received FDA 510(k) clearance on 2017-03-24 under 510(k) number K161680. The device is classified under product code GZT. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the MEDICON Spinal Spreading Systems?

MEDICON Spinal Spreading Systems is a medical device that received FDA 510(k) clearance on 2017-03-24. The listed applicant is Medicon EG. The 510(k) number is K161680.

When did MEDICON Spinal Spreading Systems receive FDA 510(k) clearance?

MEDICON Spinal Spreading Systems received FDA 510(k) clearance on 2017-03-24, under 510(k) number K161680.

Who is the listed applicant for MEDICON Spinal Spreading Systems?

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

What is the FDA product code for MEDICON Spinal Spreading Systems?

The FDA product code for MEDICON Spinal Spreading Systems is GZT.

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: GZT)

K252995Durashield Device KitSurGenTec, LLC K210615Thompson Brain Retractor Table Mounted (TM), Thompson Brain Retractor Skull Clamp Mounted (SCM)Thompson Surgical Instruments, Inc.K202694Vycor Medical Viewsite Brain Access System (“VBAS”) and VBAS with Alignment Clip (“VBAS AC”) (together the “VBAS Family”)Vycor Medical, Inc.K202072MindsEye Expandable PortMinnetronix Neuro, Inc.K180610Geister retractor for neuro - and spine surgeryGeister Medizin Technik GmbH K172433NICO BrainPathNico Corporation

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.