FDA 510(k)

Sistema de Tracción Espinal Anterior-Stand Alone (ASTS-SA)

N.º K: K233966 · 2024-04-22

Fecha de decisión2024-04-22

Código de productoOVD

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

Anterior Spine Truss System-Stand Alone (ASTS-SA) is the device name listed in this FDA 510(k) record. The listed applicant is 4Web Medical, Inc.. It received FDA 510(k) clearance on 2024-04-22 under 510(k) number K233966. The device is classified under product code OVD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Anterior Spine Truss System-Stand Alone (ASTS-SA)?

Anterior Spine Truss System-Stand Alone (ASTS-SA) is a medical device that received FDA 510(k) clearance on 2024-04-22. The listed applicant is 4Web Medical, Inc.. The 510(k) number is K233966.

When did Anterior Spine Truss System-Stand Alone (ASTS-SA) receive FDA 510(k) clearance?

Anterior Spine Truss System-Stand Alone (ASTS-SA) received FDA 510(k) clearance on 2024-04-22, under 510(k) number K233966.

Who is the listed applicant for Anterior Spine Truss System-Stand Alone (ASTS-SA)?

The FDA 510(k) record lists 4Web Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Anterior Spine Truss System-Stand Alone (ASTS-SA)?

The FDA product code for Anterior Spine Truss System-Stand Alone (ASTS-SA) is OVD.

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Otros registros que enlistan a 4Web Medical, Inc. como solicitante

K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)K240388Osteotomy Truss System (OTS)K230088Sistema de Travesaño de Tobillo (ATS)K231739Cervical Spine Truss System (CSTS)K223362Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device K221266Cervical Spine Truss System (CSTS) Interbody Fusion Device

Ver todos los 11 dispositivos →

Dispositivos relacionados (Código: OVD)

K262025Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis HAtetracell®-C Titanium Cervical IBF SystemINNO Holdings Inc. DBA Innovasis K261408SABER-XA SystemElevation Spine K261809Interwedge® Standalone LateralFoundation Surgical Group K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anchor SystemKyocera Medical Technologies, Inc.K260810Placa de Cubierta Anteralign LSTyber Medical, LLC K254202MectaLIF 3D Metal AnteriorMedacta International S.A.

Fuente oficial

Ver en la base de datos de la FDA →

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