510(k) K210989

Cirq, Cirq Robotic Alignment System, Cirq Robotic Alignment Module Cranial, Cirq Robotic Alignment Module, Cirq Robotic Alignment Cranial And Spine, CIRQ Robotic Alignment Cranial and Spine System by Brainlab AG — Product Code HAW

K210989 is an FDA 510(k) premarket notification submitted by Brainlab AG for the device "Cirq, Cirq Robotic Alignment System, Cirq Robotic Alignment Module Cranial, Cirq Robotic Alignment Module, Cirq Robotic Alignment Cranial And Spine, CIRQ Robotic Alignment Cranial and Spine System". The FDA issued a decision of Substantially Equivalent on Nov 12, 2021. The device falls under product code HAW (Neurological Stereotaxic Instrument), a Class II device regulated under 21 CFR 882.4560. Brainlab AG has 141 other 510(k) clearances on record.