510(k) K142005

SpineFab Vertebral Body Replacement (VBR) System by Oxford Performance Materials — Product Code MQP

K142005 is an FDA 510(k) premarket notification submitted by Oxford Performance Materials for the device "SpineFab Vertebral Body Replacement (VBR) System". The FDA issued a decision of Substantially Equivalent on July 10, 2015. The device falls under product code MQP (Spinal Vertebral Body Replacement Device), a Class II device regulated under 21 CFR 888.3060. Oxford Performance Materials has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 10, 2015
Date Received
July 23, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Spinal Vertebral Body Replacement Device
Device Class
Class II
Regulation Number
888.3060
Review Panel
OR
Submission Type