FDA 510(k)

Sistema Anatómico del Hombro, Sistema Anatómico del Hombro Domelock, Sistema Anatómico del Hombro para Fracturas

N.º K: K160085 · 2016-03-08

Fecha de decisión2016-03-08

Código de productoKWS

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

Anatomical Shoulder System, Anatomical Shoulder Domelock System, Anatomical Shoulder Fracture System is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer GmbH. It received FDA 510(k) clearance on 2016-03-08 under 510(k) number K160085. 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 Anatomical Shoulder System, Anatomical Shoulder Domelock System, Anatomical Shoulder Fracture System?

Anatomical Shoulder System, Anatomical Shoulder Domelock System, Anatomical Shoulder Fracture System is a medical device that received FDA 510(k) clearance on 2016-03-08. The listed applicant is Zimmer GmbH. The 510(k) number is K160085.

When did Anatomical Shoulder System, Anatomical Shoulder Domelock System, Anatomical Shoulder Fracture System receive FDA 510(k) clearance?

Anatomical Shoulder System, Anatomical Shoulder Domelock System, Anatomical Shoulder Fracture System received FDA 510(k) clearance on 2016-03-08, under 510(k) number K160085.

Who is the listed applicant for Anatomical Shoulder System, Anatomical Shoulder Domelock System, Anatomical Shoulder Fracture System?

The FDA 510(k) record lists Zimmer GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Anatomical Shoulder System, Anatomical Shoulder Domelock System, Anatomical Shoulder Fracture System?

The FDA product code for Anatomical Shoulder System, Anatomical Shoulder Domelock System, Anatomical Shoulder Fracture System is KWS.

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Otros registros que enlistan a Zimmer GmbH como solicitante

K211047CoCr Head K200814Sistema de Uñas Naturales Affixus(R) Humeral Nail(R)K200112Zimmer Hip Joint Replacement K193099Sistema de Hombro Anatómico K193050Esbocado femoral Alloclassic Zweymuller SL, Esbocado femoral desviado Alloclassic Zweymuller SL K193030Avenir Muller Stem, Avenir Cemented Hip Stem

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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.