FDA 510(k)

White Pearl Preferred Angle Anterior Cervical Plate

Número K: K160522 · 2016-04-26

Data da decisão2016-04-26

Código do produtoKWQ

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

White Pearl Preferred Angle Anterior Cervical Plate is the device name listed in this FDA 510(k) record. The listed applicant is Osseus Fusion Systems, LLC. It received FDA 510(k) clearance on 2016-04-26 under 510(k) number K160522. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the White Pearl Preferred Angle Anterior Cervical Plate?

White Pearl Preferred Angle Anterior Cervical Plate is a medical device that received FDA 510(k) clearance on 2016-04-26. The listed applicant is Osseus Fusion Systems, LLC. The 510(k) number is K160522.

When did White Pearl Preferred Angle Anterior Cervical Plate receive FDA 510(k) clearance?

White Pearl Preferred Angle Anterior Cervical Plate received FDA 510(k) clearance on 2016-04-26, under 510(k) number K160522.

Who is the listed applicant for White Pearl Preferred Angle Anterior Cervical Plate?

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

What is the FDA product code for White Pearl Preferred Angle Anterior Cervical Plate?

The FDA product code for White Pearl Preferred Angle Anterior Cervical Plate is KWQ.

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 Osseus Fusion Systems, LLC como candidato(a)

K213590Blue Topaz Sacroiliac Screw System K181347Aries® Lumbar Interbodies K170844Gemini-C Hybrid Cervical Interbody System

Dispositivos Relacionados (Código: KWQ)

K262149corra® cervical plating systemCarlsmed, Inc.K261309Palisades™ Buttress Plate SystemBethesda Medical Devices, LLC K252776ARIES Anterior Cervical Plate SystemsZheJiang Decans Medical Devices Co., Ltd.K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.K260570corra™ cervical plating systemCarlsmed, Inc.K260697VyPlate™ Anterior Cervical Plate SystemVy Spine, 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.