FDA 510(k)

ZSFab Cervical Interbody System and ZSFab Lumbar Interbody System

N.º K: K260549 · 2026-04-24

Fecha de decisión2026-04-24

Código de productoODP

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

ZSFab Cervical Interbody System and ZSFab Lumbar Interbody System is the device name listed in this FDA 510(k) record. The listed applicant is Zsfab, Inc.. It received FDA 510(k) clearance on 2026-04-24 under 510(k) number K260549. 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 ZSFab Cervical Interbody System and ZSFab Lumbar Interbody System?

ZSFab Cervical Interbody System and ZSFab Lumbar Interbody System is a medical device that received FDA 510(k) clearance on 2026-04-24. The listed applicant is Zsfab, Inc.. The 510(k) number is K260549.

When did ZSFab Cervical Interbody System and ZSFab Lumbar Interbody System receive FDA 510(k) clearance?

ZSFab Cervical Interbody System and ZSFab Lumbar Interbody System received FDA 510(k) clearance on 2026-04-24, under 510(k) number K260549.

Who is the listed applicant for ZSFab Cervical Interbody System and ZSFab Lumbar Interbody System?

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

What is the FDA product code for ZSFab Cervical Interbody System and ZSFab Lumbar Interbody System?

The FDA product code for ZSFab Cervical Interbody System and ZSFab Lumbar 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 Zsfab, Inc. como solicitante

K261451ZSAlign Cervical Interbody System K252610ZSFab Lumbar Interbody System K232150ZSFab Cervical Interbody System K221858ZSFab Lumbar Interbody System K202488ZSFab Cervical Interbody System

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.