510(k) K062348

TIMESH SELF DRILLING SCREW by Medtronic Neurosurgery — Product Code HWC

K062348 is an FDA 510(k) premarket notification submitted by Medtronic Neurosurgery for the device "TIMESH SELF DRILLING SCREW". The FDA issued a decision of Substantially Equivalent on September 8, 2006. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. Medtronic Neurosurgery has at least 10 other 510(k) clearances on record.