FDA 510(k)

Sistema de Hombro ASHCOM, Sistema de Hombro Anatómico y Sistema de Hombro Anatómico Combinado

N.º K: K170711 · 2017-06-01

Fecha de decisión2017-06-01

Código de productoPHX

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

ASHCOM Shoulder System, Anatomical Shoulder System and Anatomical Shoulder Combined 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 2017-06-01 under 510(k) number K170711. The device is classified under product code PHX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the ASHCOM Shoulder System, Anatomical Shoulder System and Anatomical Shoulder Combined System?

ASHCOM Shoulder System, Anatomical Shoulder System and Anatomical Shoulder Combined System is a medical device that received FDA 510(k) clearance on 2017-06-01. The listed applicant is Zimmer GmbH. The 510(k) number is K170711.

When did ASHCOM Shoulder System, Anatomical Shoulder System and Anatomical Shoulder Combined System receive FDA 510(k) clearance?

ASHCOM Shoulder System, Anatomical Shoulder System and Anatomical Shoulder Combined System received FDA 510(k) clearance on 2017-06-01, under 510(k) number K170711.

Who is the listed applicant for ASHCOM Shoulder System, Anatomical Shoulder System and Anatomical Shoulder Combined 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 ASHCOM Shoulder System, Anatomical Shoulder System and Anatomical Shoulder Combined System?

The FDA product code for ASHCOM Shoulder System, Anatomical Shoulder System and Anatomical Shoulder Combined System is PHX.

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Otros registros que enlistan a Zimmer GmbH como solicitante

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Dispositivos relacionados (Código: PHX)

K260556Veritas Shoulder SystemRestor3D K261683Augment Off-Axis Instrument SystemZimmer, Inc.K260102Tornier Perform Reversa Glénoide y Tornier Perform Reversa Glénoide Aumentada del Hombro SistemaStryker Corporation (Tornier, Inc.)K261016MSS - Humeral reverse liners extensionMedacta International, SA K253992Veritas Reverse Total Shoulder SystemRestor3D K252404Comprehensive Reverse Shoulder - HA Glenosphere BaseplatesBiomet Orthopedics

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.