FDA 510(k)

Curiteva Porous PEEK Cervical Interbody Fusion System

Número K: K213030 · 2023-02-13

Data da decisão2023-02-13

Código do produtoODP

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Curiteva Porous PEEK Cervical Interbody Fusion System is the device name listed in this FDA 510(k) record. The listed applicant is Curiteva, Inc.. It received FDA 510(k) clearance on 2023-02-13 under 510(k) number K213030. 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 Curiteva Porous PEEK Cervical Interbody Fusion System?

Curiteva Porous PEEK Cervical Interbody Fusion System is a medical device that received FDA 510(k) clearance on 2023-02-13. The listed applicant is Curiteva, Inc.. The 510(k) number is K213030.

When did Curiteva Porous PEEK Cervical Interbody Fusion System receive FDA 510(k) clearance?

Curiteva Porous PEEK Cervical Interbody Fusion System received FDA 510(k) clearance on 2023-02-13, under 510(k) number K213030.

Who is the listed applicant for Curiteva Porous PEEK Cervical Interbody Fusion System?

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

What is the FDA product code for Curiteva Porous PEEK Cervical Interbody Fusion System?

The FDA product code for Curiteva Porous PEEK 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_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 Curiteva, Inc. como candidato(a)

K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody System; Curiteva Porous PEEK Laminoplasty System; Curiteva Porous PEEK Standalone ALIF System K254061Curiteva Porous PEEK Cervical Interbody Fusion System K250845Curiteva Porous PEEK Standalone ALIF System K243137Curiteva Porous PEEK Laminoplasty System K233360Curiteva Thoracolumbar Plate System K233744Curiteva Porous PEEK Lumbar Interbody Fusion System

Ver todos os 11 dispositivos →

Dispositivos Relacionados (Código: ODP)

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 Spine K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC K260840BluEX 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.