510(k) K242351

Zeta Cranial Navigation System (ZNS131-US) by Zeta Surgical, Inc. — Product Code HAW

K242351 is an FDA 510(k) premarket notification submitted by Zeta Surgical, Inc. for the device "Zeta Cranial Navigation System (ZNS131-US)". The FDA issued a decision of Substantially Equivalent on October 4, 2024. The device falls under product code HAW (Neurological Stereotaxic Instrument), a Class II device regulated under 21 CFR 882.4560. Zeta Surgical, Inc. has at least 5 other 510(k) clearances on record.