FDA 510(k)

Uni-C Cervical Cage System

Número K: K252774 · 2026-04-15

RequerenteZheJiang Decans Medical Devices Co., Ltd.

Data da decisão2026-04-15

Código do produtoOVE

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Uni-C Cervical Cage System is the device name listed in this FDA 510(k) record. The listed applicant is ZheJiang Decans Medical Devices Co., Ltd.. It received FDA 510(k) clearance on 2026-04-15 under 510(k) number K252774. The device is classified under product code OVE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Uni-C Cervical Cage System?

Uni-C Cervical Cage System is a medical device that received FDA 510(k) clearance on 2026-04-15. The listed applicant is ZheJiang Decans Medical Devices Co., Ltd.. The 510(k) number is K252774.

When did Uni-C Cervical Cage System receive FDA 510(k) clearance?

Uni-C Cervical Cage System received FDA 510(k) clearance on 2026-04-15, under 510(k) number K252774.

Who is the listed applicant for Uni-C Cervical Cage System?

The FDA 510(k) record lists ZheJiang Decans Medical Devices Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Uni-C Cervical Cage System?

The FDA product code for Uni-C Cervical Cage System is OVE.

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 ZheJiang Decans Medical Devices Co., Ltd. como candidato(a)

K253046HERA Interlocking Intramedullary Nailing System K253195TAURUS Posterior Occipital-Cervico-Thoracic Spinal Systems K253130Dione PEEK Screw System K252930Sistemas de Laminoplastia AQUA K252776ARIES Anterior Cervical Plate Systems K252542LEO Spinal System

Ver todos os 11 dispositivos →

Dispositivos Relacionados (Código: OVE)

K263049SABER-C SystemElevation Spine K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC K261451ZSAlign Cervical Interbody SystemZSFab, Inc.K262094E3D™-C Interbody SystemEvolution Spine K261279DeltaNEC Interbody SystemNexus Spine K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, 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.