510(k) K030833

DEPUY ACROMED VBR SYSTEM by Depuyacromed — Product Code MQP

K030833 is an FDA 510(k) premarket notification submitted by Depuyacromed for the device "DEPUY ACROMED VBR SYSTEM". The FDA issued a decision of Substantially Equivalent on April 10, 2003. The device falls under product code MQP (Spinal Vertebral Body Replacement Device), a Class II device regulated under 21 CFR 888.3060. Depuyacromed has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 10, 2003
Date Received
March 17, 2003
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