FDA 510(k)

Sistema de Truss de Coluna Anterior – Stand Alone (ASTS-SA) para Fusão Interespinhal

Número K: K200002 · 2020-05-29

Data da decisão2020-05-29

Código do produtoOVD

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Anterior Spine Truss System – Stand Alone (ASTS-SA) 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 2020-05-29 under 510(k) number K200002. The device is classified under product code OVD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Anterior Spine Truss System – Stand Alone (ASTS-SA) Interbody Fusion Device?

Anterior Spine Truss System – Stand Alone (ASTS-SA) Interbody Fusion Device is a medical device that received FDA 510(k) clearance on 2020-05-29. The listed applicant is 4Web, Inc.. The 510(k) number is K200002.

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

Anterior Spine Truss System – Stand Alone (ASTS-SA) Interbody Fusion Device received FDA 510(k) clearance on 2020-05-29, under 510(k) number K200002.

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

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

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Outros registros que listam 4Web, Inc. como candidato(a)

K253201Lumbar Spine Truss System - Plating Solution (LSTS-PS)K203065Lumbar Spine Truss System Plating Solution (LSTS-PS)K190870Cervical Spinal Truss System-Stand Alone (CSTS-SA)K190926Hammertoe Truss System (HTS)K172294Osteotomy Truss System (OTS)K173159Cervical Spinal Truss System (CSTS) Interbody Fusion Device

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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.K260810Anteralign LS coverplateTyber Medical, LLC K254202MectaLIF 3D Metal AnteriorMedacta International S.A.

Fonte oficial

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