Cleared Traditional

SpineFab Vertebral Body Replacement (VBR) System

K142005 · Oxford Performance Materials · Orthopedic

Jul 2015

Decision

352d

Days

Class 2

Risk

About This 510(k) Submission

K142005 is an FDA 510(k) clearance for the SpineFab Vertebral Body Replacement (VBR) System, a Spinal Vertebral Body Replacement Device (Class II — Special Controls, product code MQP), submitted by Oxford Performance Materials (South Windsor, US). The FDA issued a Cleared decision on July 10, 2015, 352 days after receiving the submission on July 23, 2014. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3060.

Submission Details

510(k) Number	K142005 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 23, 2014
Decision Date	July 10, 2015
Days to Decision	352 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF