FDA 510(k)

FIX-C PEEK Anterior Cervical Interbody System

N.º K: K212266 · 2021-12-21

Fecha de decisión2021-12-21

Código de productoODP

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

FIX-C PEEK Anterior Cervical Interbody System is the device name listed in this FDA 510(k) record. The listed applicant is Jeil Medical Corporation. It received FDA 510(k) clearance on 2021-12-21 under 510(k) number K212266. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the FIX-C PEEK Anterior Cervical Interbody System?

FIX-C PEEK Anterior Cervical Interbody System is a medical device that received FDA 510(k) clearance on 2021-12-21. The listed applicant is Jeil Medical Corporation. The 510(k) number is K212266.

When did FIX-C PEEK Anterior Cervical Interbody System receive FDA 510(k) clearance?

FIX-C PEEK Anterior Cervical Interbody System received FDA 510(k) clearance on 2021-12-21, under 510(k) number K212266.

Who is the listed applicant for FIX-C PEEK Anterior Cervical Interbody System?

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

What is the FDA product code for FIX-C PEEK Anterior Cervical Interbody System?

The FDA product code for FIX-C PEEK Anterior Cervical Interbody System is ODP.

Ensayos clínicos relacionados

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

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

Otros registros que enlistan a Jeil Medical Corporation como solicitante

K252246Leforte MMF System K252826ARIX Femur Nail System K251431FIX-C PEEK ACIF SA System K243973FIX-L PEEK PLIF and T-PLIF System K242751Sistema ARIX Pectus Bar K242247ARIX Femur Nail System

Ver todos los 35 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.

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.