FDA 510(k)

LATERAL Spine Truss System

Número K: K153436 · 2016-06-06

Data da decisão2016-06-06

Código do produtoMAX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

LATERAL Spine Truss System is the device name listed in this FDA 510(k) record. The listed applicant is 4Web, Inc.. It received FDA 510(k) clearance on 2016-06-06 under 510(k) number K153436. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the LATERAL Spine Truss System?

LATERAL Spine Truss System is a medical device that received FDA 510(k) clearance on 2016-06-06. The listed applicant is 4Web, Inc.. The 510(k) number is K153436.

When did LATERAL Spine Truss System receive FDA 510(k) clearance?

LATERAL Spine Truss System received FDA 510(k) clearance on 2016-06-06, under 510(k) number K153436.

Who is the listed applicant for LATERAL Spine Truss System?

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 LATERAL Spine Truss System?

The FDA product code for LATERAL Spine Truss System is MAX.

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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)K200002Sistema de Truss de Coluna Anterior – Stand Alone (ASTS-SA) para Fusão Interespinhal K190870Cervical Spinal Truss System-Stand Alone (CSTS-SA)K190926Hammertoe Truss System (HTS)K172294Osteotomy Truss System (OTS)

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Fonte oficial

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