FDA 510(k)

Cervical Spinal Truss System (CSTS) Interbody Fusion Device

N.º K: K173159 · 2018-01-08

Fecha de decisión2018-01-08

Código de productoODP

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

Cervical Spinal Truss System (CSTS) Interbody Fusion Device is the device name listed in this FDA 510(k) record. The listed applicant is 4Web, Inc.. It received FDA 510(k) clearance on 2018-01-08 under 510(k) number K173159. 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 Cervical Spinal Truss System (CSTS) Interbody Fusion Device?

Cervical Spinal Truss System (CSTS) Interbody Fusion Device is a medical device that received FDA 510(k) clearance on 2018-01-08. The listed applicant is 4Web, Inc.. The 510(k) number is K173159.

When did Cervical Spinal Truss System (CSTS) Interbody Fusion Device receive FDA 510(k) clearance?

Cervical Spinal Truss System (CSTS) Interbody Fusion Device received FDA 510(k) clearance on 2018-01-08, under 510(k) number K173159.

Who is the listed applicant for Cervical Spinal Truss System (CSTS) Interbody Fusion Device?

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

What is the FDA product code for Cervical Spinal Truss System (CSTS) Interbody Fusion Device?

The FDA product code for Cervical Spinal Truss System (CSTS) Interbody Fusion Device is ODP.

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

K253201Lumbar Spine Truss System - Plating Solution (LSTS-PS)K203065Lumbar Spine Truss System Plating Solution (LSTS-PS)K200002Sistema de Tracción Espinal Anterior – Independiente (ASTS-SA) Dispositivo de Fusion Interespinal K190870Cervical Spinal Truss System-Stand Alone (CSTS-SA)K190926Hammertoe Truss System (HTS)K172294Osteotomy Truss System (OTS)

Ver todos los 11 dispositivos →

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

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