FDA 510(k)

Unison-C Anterior Cervical Fixation System

Número K: K170830 · 2017-06-28

RequerentePioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.

Data da decisão2017-06-28

Código do produtoOVE

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Unison-C Anterior Cervical Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.. It received FDA 510(k) clearance on 2017-06-28 under 510(k) number K170830. 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 Unison-C Anterior Cervical Fixation System?

Unison-C Anterior Cervical Fixation System is a medical device that received FDA 510(k) clearance on 2017-06-28. The listed applicant is Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.. The 510(k) number is K170830.

When did Unison-C Anterior Cervical Fixation System receive FDA 510(k) clearance?

Unison-C Anterior Cervical Fixation System received FDA 510(k) clearance on 2017-06-28, under 510(k) number K170830.

Who is the listed applicant for Unison-C Anterior Cervical Fixation System?

The FDA 510(k) record lists Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Unison-C Anterior Cervical Fixation System?

The FDA product code for Unison-C Anterior Cervical Fixation 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 Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc. como candidato(a)

K201497EVOS Cabling System K200095Streamline Navigated Instruments K193468Tritium Sternal Cable Plate System K192800Streamline TL Spinal Fixation System K192718Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D Technology K190498Fortilink® IBF System with TETRAfuse®3D Technology, include the following designs: Fortilink®-TS IBF System, Fortilink®-L I BF System, Fortilink®-C IBF System

Ver todos os 13 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.