510(k) K161318

Phantom Fukushima Neurological Holding Systems, Phantom Mastability Neurological Holding Systems by Tedan Surgical Innovations, LLC — Product Code GZT

K161318 is an FDA 510(k) premarket notification submitted by Tedan Surgical Innovations, LLC for the device "Phantom Fukushima Neurological Holding Systems, Phantom Mastability Neurological Holding Systems". The FDA issued a decision of Substantially Equivalent on March 20, 2017. The device falls under product code GZT (Retractor, Self-Retaining, For Neurosurgery), a Class II device regulated under 21 CFR 882.4800. Tedan Surgical Innovations, LLC has at least 3 other 510(k) clearances on record.