FDA 510(k)

BIOLOX Delta Ceramic Femoral Heads, BIOLOX Option Ceramic Femoral Head System

N.º K: K192416 · 2019-10-01

Fecha de decisión2019-10-01

Código de productoLZO

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

BIOLOX Delta Ceramic Femoral Heads, BIOLOX Option Ceramic Femoral Head 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 2019-10-01 under 510(k) number K192416. The device is classified under product code LZO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the BIOLOX Delta Ceramic Femoral Heads, BIOLOX Option Ceramic Femoral Head System?

BIOLOX Delta Ceramic Femoral Heads, BIOLOX Option Ceramic Femoral Head System is a medical device that received FDA 510(k) clearance on 2019-10-01. The listed applicant is Zimmer GmbH. The 510(k) number is K192416.

When did BIOLOX Delta Ceramic Femoral Heads, BIOLOX Option Ceramic Femoral Head System receive FDA 510(k) clearance?

BIOLOX Delta Ceramic Femoral Heads, BIOLOX Option Ceramic Femoral Head System received FDA 510(k) clearance on 2019-10-01, under 510(k) number K192416.

Who is the listed applicant for BIOLOX Delta Ceramic Femoral Heads, BIOLOX Option Ceramic Femoral Head 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 BIOLOX Delta Ceramic Femoral Heads, BIOLOX Option Ceramic Femoral Head System?

The FDA product code for BIOLOX Delta Ceramic Femoral Heads, BIOLOX Option Ceramic Femoral Head System is LZO.

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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: LZO)

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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.