STRYKER NAVIGATION SYSTEM - CRANIAL MODULE, MODEL 6000-650-000

About This 510(k) Submission

K062640 is an FDA 510(k) clearance for the STRYKER NAVIGATION SYSTEM - CRANIAL MODULE, MODEL 6000-650-000, a Neurological Stereotaxic Instrument (Class II — Special Controls, product code HAW), submitted by Stryker Instruments (Kalamazoo, US). The FDA issued a Cleared decision on December 14, 2006, 99 days after receiving the submission on September 6, 2006. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4560.