510(k) K073125

VALEO VBR by Amedica Corp. — Product Code MQP

K073125 is an FDA 510(k) premarket notification submitted by Amedica Corp. for the device "VALEO VBR". The FDA issued a decision of Substantially Equivalent on December 5, 2007. The device falls under product code MQP (Spinal Vertebral Body Replacement Device), a Class II device regulated under 21 CFR 888.3060. Amedica Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 5, 2007
Date Received
November 6, 2007
Clearance Type
Special
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