FDA 510(k)

INLIANT Surgical Navigation System

N.º K: K213392 · 2022-02-22

SolicitanteNavigate Surgical Technologies, Inc.

Fecha de decisión2022-02-22

Código de productoPLV

Comité asesorDE

DecisiónSubstantially Equivalent

Resumen del dispositivo

INLIANT Surgical Navigation System is the device name listed in this FDA 510(k) record. The listed applicant is Navigate Surgical Technologies, Inc.. It received FDA 510(k) clearance on 2022-02-22 under 510(k) number K213392. The device is classified under product code PLV. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the INLIANT Surgical Navigation System?

INLIANT Surgical Navigation System is a medical device that received FDA 510(k) clearance on 2022-02-22. The listed applicant is Navigate Surgical Technologies, Inc.. The 510(k) number is K213392.

When did INLIANT Surgical Navigation System receive FDA 510(k) clearance?

INLIANT Surgical Navigation System received FDA 510(k) clearance on 2022-02-22, under 510(k) number K213392.

Who is the listed applicant for INLIANT Surgical Navigation System?

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

What is the FDA product code for INLIANT Surgical Navigation System?

The FDA product code for INLIANT Surgical Navigation System is PLV.

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Fuente oficial

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