510(k) K092239

ROSA SURGICAL DEVICE, MODEL ROSA 1.1 by Medtech S.A — Product Code HAW

K092239 is an FDA 510(k) premarket notification submitted by Medtech S.A for the device "ROSA SURGICAL DEVICE, MODEL ROSA 1.1". The FDA issued a decision of Substantially Equivalent on November 17, 2009. The device falls under product code HAW (Neurological Stereotaxic Instrument), a Class II device regulated under 21 CFR 882.4560. Medtech S.A has at least 10 other 510(k) clearances on record.