510(k) K110925

NOVABONE MACROPOR-SI+ - BIOACTIVE BONE GRAFT by Novabone Products, LLC — Product Code MQV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 5, 2011
Date Received
April 1, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Filler, Bone Void, Calcium Compound
Device Class
Class II
Regulation Number
888.3045
Review Panel
OR
Submission Type