510(k) K071849

ALLOFUSE GEL AND PUTTY by Allosource, Inc. — Product Code MQV

K071849 is an FDA 510(k) premarket notification submitted by Allosource, Inc. for the device "ALLOFUSE GEL AND PUTTY". The FDA issued a decision of Substantially Equivalent on December 4, 2008. The device falls under product code MQV (Filler, Bone Void, Calcium Compound), a Class II device regulated under 21 CFR 888.3045. Allosource, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 4, 2008
Date Received
July 5, 2007
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