OBELISC VERTEBRAL BODY REPLACEMENT DEVICE

About This 510(k) Submission

K060416 is an FDA 510(k) clearance for the OBELISC VERTEBRAL BODY REPLACEMENT DEVICE, a Spinal Vertebral Body Replacement Device (Class II — Special Controls, product code MQP), submitted by Ulrich GmbH & Co. KG (Clearwater, US). The FDA issued a Cleared decision on December 26, 2006, 312 days after receiving the submission on February 17, 2006. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3060.