510(k) K202320

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

K202320 is an FDA 510(k) premarket notification submitted by Brainlab AG for the device "CIRQ Robotic Alignment Module, Cirq, Cirq Robotic Alignment Module Spinal, Cirq Robotic Alignment Cranial and Spine, CIRQ Robotic Alignment Cranial and Spine System". The FDA issued a decision of Substantially Equivalent on Dec 23, 2020. The device falls under product code OLO (Orthopedic Stereotaxic Instrument), a Class II device regulated under 21 CFR 882.4560. Brainlab AG has 141 other 510(k) clearances on record.