510(k) K062814

PIPELINE II ACCESS SYSTEM by Depuy Spine, Inc. — Product Code GZT

K062814 is an FDA 510(k) premarket notification submitted by Depuy Spine, Inc. for the device "PIPELINE II ACCESS SYSTEM". The FDA issued a decision of Substantially Equivalent on December 15, 2006. The device falls under product code GZT (Retractor, Self-Retaining, For Neurosurgery), a Class II device regulated under 21 CFR 882.4800. Depuy Spine, Inc. has at least 10 other 510(k) clearances on record.