510(k) K112773

NOVABNE PUTTY BIOACTIVE SYNTHETIC BONE GRAFT by Novabone Products, LLC — Product Code MQV

K112773 is an FDA 510(k) premarket notification submitted by Novabone Products, LLC for the device "NOVABNE PUTTY BIOACTIVE SYNTHETIC BONE GRAFT". The FDA issued a decision of Substantially Equivalent on October 14, 2011. The device falls under product code MQV (Filler, Bone Void, Calcium Compound), a Class II device regulated under 21 CFR 888.3045. Novabone Products, LLC has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 14, 2011
Date Received
September 23, 2011
Clearance Type
Special
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