inforMED
SIQClass II

Intra-articular Orthopedic Stereotaxic Navigation Instrument

Orthopedic · 21 CFR 888.4561

An intra-articular orthopedic stereotaxic navigation instrument is a device consisting of a rigid frame of reference with a calibrated guide mechanism and fiducial markers temporarily affixed to anatomical structures within the intraarticular space. The markers are continuously tracked for precisely positioning instruments or other devices.

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Registered firms3Currently listed
510(k) clearances1All time

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