510(k) K180610

Geister retractor for neuro - and spine surgery by Geister Medizin Technik GmbH — Product Code GZT

K180610 is an FDA 510(k) premarket notification submitted by Geister Medizin Technik GmbH for the device "Geister retractor for neuro - and spine surgery". The FDA issued a decision of Substantially Equivalent on August 29, 2018. The device falls under product code GZT (Retractor, Self-Retaining, For Neurosurgery), a Class II device regulated under 21 CFR 882.4800. Geister Medizin Technik GmbH has at least 5 other 510(k) clearances on record.