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FDA 510(k)

Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody System; WaveForm TO Interbody System; WaveForm TA Interbody System; FORZA XP Expandable Spacer System; Shoreline ACS Interbody System; Shoreline RT Interbody System; Meridian Interbody System; WaveForm A Interbody System

N.º K: K240830 · 2024-06-20

SolicitanteOrthofix Medical, Inc.
Fecha de decisión2024-06-20
Código de productoMAX
Comité asesorOR
DecisiónSubstantially Equivalent

Resumen del dispositivo

Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody System; WaveForm TO Interbody System; WaveForm TA Interbody System; FORZA XP Expandable Spacer System; Shoreline ACS Interbody System; Shoreline RT Interbody System; Meridian Interbody System; WaveForm A Interbody System is the device name listed in this FDA 510(k) record. The listed applicant is Orthofix Medical, Inc.. It received FDA 510(k) clearance on 2024-06-20 under 510(k) number K240830. 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 Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody System; WaveForm TO Interbody System; WaveForm TA Interbody System; FORZA XP Expandable Spacer System; Shoreline ACS Interbody System; Shoreline RT Interbody System; Meridian Interbody System; WaveForm A Interbody System?

Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody System; WaveForm TO Interbody System; WaveForm TA Interbody System; FORZA XP Expandable Spacer System; Shoreline ACS Interbody System; Shoreline RT Interbody System; Meridian Interbody System; WaveForm A Interbody System is a medical device that received FDA 510(k) clearance on 2024-06-20. The listed applicant is Orthofix Medical, Inc.. The 510(k) number is K240830.

When did Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody System; WaveForm TO Interbody System; WaveForm TA Interbody System; FORZA XP Expandable Spacer System; Shoreline ACS Interbody System; Shoreline RT Interbody System; Meridian Interbody System; WaveForm A Interbody System receive FDA 510(k) clearance?

Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody System; WaveForm TO Interbody System; WaveForm TA Interbody System; FORZA XP Expandable Spacer System; Shoreline ACS Interbody System; Shoreline RT Interbody System; Meridian Interbody System; WaveForm A Interbody System received FDA 510(k) clearance on 2024-06-20, under 510(k) number K240830.

Who is the listed applicant for Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody System; WaveForm TO Interbody System; WaveForm TA Interbody System; FORZA XP Expandable Spacer System; Shoreline ACS Interbody System; Shoreline RT Interbody System; Meridian Interbody System; WaveForm A Interbody System?

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

What is the FDA product code for Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody System; WaveForm TO Interbody System; WaveForm TA Interbody System; FORZA XP Expandable Spacer System; Shoreline ACS Interbody System; Shoreline RT Interbody System; Meridian Interbody System; WaveForm A Interbody System?

The FDA product code for Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody System; WaveForm TO Interbody System; WaveForm TA Interbody System; FORZA XP Expandable Spacer System; Shoreline ACS Interbody System; Shoreline RT Interbody System; 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_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Dispositivos relacionados (Código: MAX)

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.

K261049SCALA® TLSpineart SAK261430TruLift Expandable SystemLife Spine, Inc.K253011Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.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 WaveFormSeaSpine Orthopedics CorporationK253151Sistema de Caja de Fusion Interbody FuleBeijing Fule Science & Technology Development 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.

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