510(k) K080355

LEKSELL STEREOTACTIC SYSTEM WITH REUSABLE FIXATION SCREWS by Elekta Instrument AB — Product Code HAW

K080355 is an FDA 510(k) premarket notification submitted by Elekta Instrument AB for the device "LEKSELL STEREOTACTIC SYSTEM WITH REUSABLE FIXATION SCREWS". The FDA issued a decision of Substantially Equivalent on May 1, 2009. The device falls under product code HAW (Neurological Stereotaxic Instrument), a Class II device regulated under 21 CFR 882.4560. Elekta Instrument AB has at least 10 other 510(k) clearances on record.