FDA 510(k)

SmartBase for Arthrex Glenoid IRIS

N.º K: K153215 · 2016-02-19

SolicitanteCustom Orthopaedic Solutions, Inc.

Fecha de decisión2016-02-19

Código de productoKWS

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

SmartBase for Arthrex Glenoid IRIS is the device name listed in this FDA 510(k) record. The listed applicant is Custom Orthopaedic Solutions, Inc.. It received FDA 510(k) clearance on 2016-02-19 under 510(k) number K153215. The device is classified under product code KWS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the SmartBase for Arthrex Glenoid IRIS?

SmartBase for Arthrex Glenoid IRIS is a medical device that received FDA 510(k) clearance on 2016-02-19. The listed applicant is Custom Orthopaedic Solutions, Inc.. The 510(k) number is K153215.

When did SmartBase for Arthrex Glenoid IRIS receive FDA 510(k) clearance?

SmartBase for Arthrex Glenoid IRIS received FDA 510(k) clearance on 2016-02-19, under 510(k) number K153215.

Who is the listed applicant for SmartBase for Arthrex Glenoid IRIS?

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

What is the FDA product code for SmartBase for Arthrex Glenoid IRIS?

The FDA product code for SmartBase for Arthrex Glenoid IRIS is KWS.

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Otros registros que enlistan a Custom Orthopaedic Solutions, Inc. como solicitante

K162697Sistema de Instrumento Reutilizable Inteligente de Glenoid Arthrex, Plan de Preoperatorio OrthoVis Arthrex, SmartBase para Glenoid IRIS de Arthrex, Portal Web ArthrexVIP K153612Portal Web VIP de Arthrex

Dispositivos relacionados (Código: KWS)

K260721Tornier Perform Advanced GlenoidTornier, Inc.K254084Sistema de Hombro AETOS - CONCELOC GlenoidsSmith & Nephew, Inc.K252418Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.K252416Prótesis Humeral Meta AETOS Shoulder System Size 0Smith & Nephew, Inc.K241292MyShoulder Planner (5.3SSWPL)Medacta International S.A.K241878Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem)Stryker Corporation (Tornier, Inc.)

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.