FDA 510(k)

Meridian Interbody System; WaveForm A Interbody System

N.º K: K233694 · 2024-01-12

SolicitanteSeaSpine Orthopedics Corporation

Fecha de decisión2024-01-12

Código de productoMAX

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

Meridian Interbody System; WaveForm A Interbody System is the device name listed in this FDA 510(k) record. The listed applicant is SeaSpine Orthopedics Corporation. It received FDA 510(k) clearance on 2024-01-12 under 510(k) number K233694. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Meridian Interbody System; WaveForm A Interbody System?

Meridian Interbody System; WaveForm A Interbody System is a medical device that received FDA 510(k) clearance on 2024-01-12. The listed applicant is SeaSpine Orthopedics Corporation. The 510(k) number is K233694.

When did Meridian Interbody System; WaveForm A Interbody System receive FDA 510(k) clearance?

Meridian Interbody System; WaveForm A Interbody System received FDA 510(k) clearance on 2024-01-12, under 510(k) number K233694.

Who is the listed applicant for Meridian Interbody System; WaveForm A Interbody System?

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

What is the FDA product code for Meridian Interbody System; WaveForm A Interbody System?

The FDA product code for Meridian Interbody System; WaveForm A Interbody System is MAX.

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 SeaSpine Orthopedics Corporation como solicitante

K253420Sistema Admiral ACP; Sistema Explorer TO; Sistema de Laminoplastia; Espaciador TDF Manta Ray; Sistema Interbody Meridian; Sistema de Placa Anterior Meridian; Sistema Interbody L Reef; Sistema TO/TA Reef; Sistema Lateral Regatta; Sistema de Placa Lateral Regatta; Sistema Interbody ACS Shoreline; Placa TruProfile Entornada Shoreline; Sistema Interbody RT Shoreline; Malla Vu; Sistema Interbody A WaveForm; Sistema Interbody C WaveForm; Sistema Interbody L WaveForm; Sistema Interbody TA WaveForm; Sistema Interbody TO WaveForm K250908Virata Spinal Fixation System K243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion Instruments K242273Cove Putty, OsteoCove Putty K241466Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System; Reef L Interbody System; Reef TO/TA System; Meridian Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TO Interbody System; WaveForm TA Interbody System; WaveForm A Interbody System K240566Reef L Interbody System; WaveForm L Interbody System

Ver todos los 67 dispositivos →

Dispositivos relacionados (Código: MAX)

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.