510(k) K163322

TZ SKULL PIN Adult by Tz Medical, Inc. — Product Code HBL

K163322 is an FDA 510(k) premarket notification submitted by Tz Medical, Inc. for the device "TZ SKULL PIN Adult". The FDA issued a decision of Substantially Equivalent on February 23, 2017. The device falls under product code HBL (Holder, Head, Neurosurgical (Skull Clamp)), a Class II device regulated under 21 CFR 882.4460. Tz Medical, Inc. has at least 10 other 510(k) clearances on record.