FDA 510(k)

K&J IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage

N.º K: K212038 · 2021-08-27

Fecha de decisión2021-08-27

Código de productoODP

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

K&J IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage is the device name listed in this FDA 510(k) record. The listed applicant is K&J Consulting Corporation. It received FDA 510(k) clearance on 2021-08-27 under 510(k) number K212038. 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 K&J IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage?

K&J IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage is a medical device that received FDA 510(k) clearance on 2021-08-27. The listed applicant is K&J Consulting Corporation. The 510(k) number is K212038.

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

K&J IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage received FDA 510(k) clearance on 2021-08-27, under 510(k) number K212038.

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

The FDA 510(k) record lists K&J Consulting Corporation as the applicant. This does not by itself establish the device manufacturer.

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

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

Otros registros que enlistan a K&J Consulting Corporation como solicitante

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Fuente oficial

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