Aviso: Este site agrega dados públicos oficiais da FDA, ClinicalTrials.gov, PubMed e SEC EDGAR apenas para referência geral. Não constitui aconselhamento médico, diagnóstico, recomendação de tratamento ou aconselhamento de investimento.

FDA 510(k)

Tailored-C Cervical Interbody Fusion System

Número K: K200458 · 2020-12-28

RequerenteBespoke Technologies
Data da decisão2020-12-28
Código do produtoODP
Comité consultivoOR
DecisãoSubstantially Equivalent

Resumo do dispositivo

Tailored-C Cervical Interbody Fusion System is the device name listed in this FDA 510(k) record. The listed applicant is Bespoke Technologies. It received FDA 510(k) clearance on 2020-12-28 under 510(k) number K200458. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Tailored-C Cervical Interbody Fusion System?

Tailored-C Cervical Interbody Fusion System is a medical device that received FDA 510(k) clearance on 2020-12-28. The listed applicant is Bespoke Technologies. The 510(k) number is K200458.

When did Tailored-C Cervical Interbody Fusion System receive FDA 510(k) clearance?

Tailored-C Cervical Interbody Fusion System received FDA 510(k) clearance on 2020-12-28, under 510(k) number K200458.

Who is the listed applicant for Tailored-C Cervical Interbody Fusion System?

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

What is the FDA product code for Tailored-C Cervical Interbody Fusion System?

The FDA product code for Tailored-C Cervical Interbody Fusion System is ODP.

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_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Dispositivos Relacionados (Código: ODP)

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.

K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.K262489BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.K2530413d Cage CervicalFims Co., Ltd.K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior Lumbar Cage; Aero® -C Cervical Cage System; AVS® Anchor-C Cervical Cage System; AVS® TL PEEK Spacer; AVS® PL PEEK Spacers; AVS® Navigator PEEK Spacer; AVS® AS PEEK Spacer; Monterey™ AL Interbody System; Aleutian IBF System; Cascadia Interbody System; Chesapeake Stabilization System; Sahara Stabilization System; SANTORINI™ Corpectomy Cage System; MOJAVE Interbody System; VLIFT VERTEBRAL BODY REPLACEMStryker SpineK254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLCK260840BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.

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.

↑