FDA 510(k)

CROSSNAV Navigation Enabled Instruments and UNAS Navigation Arrays

N.º K: K241893 · 2024-09-16

Fecha de decisión2024-09-16

Código de productoOLO

Comité asesorNE

DecisiónSubstantially Equivalent

Resumen del dispositivo

CROSSNAV Navigation Enabled Instruments and UNAS Navigation Arrays is the device name listed in this FDA 510(k) record. The listed applicant is Medos International SARL. It received FDA 510(k) clearance on 2024-09-16 under 510(k) number K241893. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the CROSSNAV Navigation Enabled Instruments and UNAS Navigation Arrays?

CROSSNAV Navigation Enabled Instruments and UNAS Navigation Arrays is a medical device that received FDA 510(k) clearance on 2024-09-16. The listed applicant is Medos International SARL. The 510(k) number is K241893.

When did CROSSNAV Navigation Enabled Instruments and UNAS Navigation Arrays receive FDA 510(k) clearance?

CROSSNAV Navigation Enabled Instruments and UNAS Navigation Arrays received FDA 510(k) clearance on 2024-09-16, under 510(k) number K241893.

Who is the listed applicant for CROSSNAV Navigation Enabled Instruments and UNAS Navigation Arrays?

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

What is the FDA product code for CROSSNAV Navigation Enabled Instruments and UNAS Navigation Arrays?

The FDA product code for CROSSNAV Navigation Enabled Instruments and UNAS Navigation Arrays is OLO.

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 Medos International SARL como solicitante

K254157CROSSNAV Navigation Enabled Instruments for Disc Preparation and Interbody K260240SYMPHONY Navigation Ready Instruments K253249TriALTIS™ Spine System K243249TriALTIS™ Spine System K242042TriALTIS™ Spine System K233684TriALTIS™ Spine System

Ver todos los 75 dispositivos →

Dispositivos relacionados (Código: OLO)

K262506Remex Spine Surgery Navigation - Universal InstrumentsRemex Medical Corp.K261410Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration Kit))Suite 201, National Innovation Centre K261205SPINEART Navigation Instrument SystemSpineart SA K261024TMINI Miniature Robotic SystemTHINK Surgical, Inc.K262121Ion-L Navigated InstrumentsSurGenTec, LLC K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics

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.