510(k) K073505

MODIFICATION TO VALEO VBR by Amedica Corp. — Product Code MQP

K073505 is an FDA 510(k) premarket notification submitted by Amedica Corp. for the device "MODIFICATION TO VALEO VBR". The FDA issued a decision of Substantially Equivalent on January 9, 2008. 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
January 9, 2008
Date Received
December 13, 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