510(k) K050897

NAVIPRO SHOULDER SOFTWARE MODULE by Kinamed, Inc. — Product Code HAW

K050897 is an FDA 510(k) premarket notification submitted by Kinamed, Inc. for the device "NAVIPRO SHOULDER SOFTWARE MODULE". The FDA issued a decision of Substantially Equivalent on May 24, 2005. The device falls under product code HAW (Neurological Stereotaxic Instrument), a Class II device regulated under 21 CFR 882.4560. Kinamed, Inc. has at least 10 other 510(k) clearances on record.