FDA 510(k)

Pisces-SC Standalone Cervical Interbody System

N.º K: K261882 · 2026-08-21

Fecha de decisión2026-08-21

Código de productoOVE

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

Pisces-SC Standalone Cervical Interbody System is the device name listed in this FDA 510(k) record. The listed applicant is Osseus Fusions Systems, LLC. It received FDA 510(k) clearance on 2026-08-21 under 510(k) number K261882. The device is classified under product code OVE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Pisces-SC Standalone Cervical Interbody System?

Pisces-SC Standalone Cervical Interbody System is a medical device that received FDA 510(k) clearance on 2026-08-21. The listed applicant is Osseus Fusions Systems, LLC. The 510(k) number is K261882.

When did Pisces-SC Standalone Cervical Interbody System receive FDA 510(k) clearance?

Pisces-SC Standalone Cervical Interbody System received FDA 510(k) clearance on 2026-08-21, under 510(k) number K261882.

Who is the listed applicant for Pisces-SC Standalone Cervical Interbody System?

The FDA 510(k) record lists Osseus Fusions Systems, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Pisces-SC Standalone Cervical Interbody System?

The FDA product code for Pisces-SC Standalone Cervical Interbody System is OVE.

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Dispositivos relacionados (Código: OVE)

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Fuente oficial

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