FDA 510(k)

Medynus IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage

N.º K: K212792 · 2021-09-23

Fecha de decisión2021-09-23

Código de productoODP

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

Medynus IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage is the device name listed in this FDA 510(k) record. The listed applicant is Medynus, Inc.. It received FDA 510(k) clearance on 2021-09-23 under 510(k) number K212792. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Medynus IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage?

Medynus IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage is a medical device that received FDA 510(k) clearance on 2021-09-23. The listed applicant is Medynus, Inc.. The 510(k) number is K212792.

When did Medynus IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage receive FDA 510(k) clearance?

Medynus IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage received FDA 510(k) clearance on 2021-09-23, under 510(k) number K212792.

Who is the listed applicant for Medynus IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage?

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

What is the FDA product code for Medynus IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage?

The FDA product code for Medynus IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage is ODP.

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Fuente oficial

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